Devices, systems, and methods for treating a pelvic floor disorder

Abstract

Featured are methods, peripheral devices, and systems containing the same for use in determining the likelihood of success of pelvic floor treatment therapy. The method may include performing a treatment regimen that includes pelvic floor exercises and monitoring treatment efficacy to determine the likelihood of treatment success in order to continue treatment or employ an alternative therapy.

Description

[0001] DEVICES, SYSTEMS, AND METHODS FOR TREATING A PELVIC FLOOR DISORDER

[0002] BACKGROUND

[0003] Pelvic floor disorders (PFDs) are a group of conditions that occur predominantly in women and that are associated with weakened (e.g., hypotonic) or tense (e.g., hypertonic) pelvic floor (PF) muscles. Many common factors contribute to the weakening or tightening of the pelvic floor muscles in women, such as, for example, pregnancy, vaginal childbirth, pelvic surgery, aging, genetic predisposition, neurological disease, and weight gain. In the United States, PFDs occur in 24% of women, with 16% of women experiencing urinary incontinence (Ul), 3% experiencing pelvic organ prolapse (POP), and 9% experiencing anal or fecal incontinence (Fl). The prevalence of PFDs increases with age, such that 10% of women aged 20-39 and 50% of women aged 80 years or older will experience at least one PFD. The number of women in the United States having at least one PFD is estimated to increase from 28.1 million in 2010 to 43.8 million in 2050 (Memon et al., Womens Health (Lond. Engl.). 9(3), 2013). While pelvic floor exercises have emerged as a common technique for treating PFDs, these do not result in meaningful treatment outcomes in a number of subjects. Accordingly, improved methods and devices for diagnosing, monitoring, and treating PFDs are needed to optimize pelvic floor exercise therapy and tailor treatment regimens to maximize responsiveness.

[0004] SUMMARY OF THE INVENTION

[0005] In one aspect, featured is a method of treating a pelvic floor disorder in a subject. The method includes (a) obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and (b) processing the positional data from the one or more sensors to establish a performance metric. The method may further include (c) continuing treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, e.g., wherein the performance metric is above a predetermined threshold; or performing a second therapy that is different from the first therapy in the subject, e.g., wherein the performance metric is below the predetermined threshold. The method may further include obtaining survey questionnaire data from the subject including symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. The processing step may include processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

[0006] In another aspect, featured is a method of treating a pelvic floor disorder in a subject nonresponsive to a first therapy, e.g., a first therapy that includes pelvic floor exercises with the intravaginal device. The method includes treating the subject with a second therapy that is different from the first therapy, e.g., wherein the subject has previously been determined to be nonresponsive to the first therapy by (a) obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of the first therapy. The subject has previously been determined to be nonresponsive by (b) processing the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy; and (c) determining that the performance metric is below a predetermined threshold. In another aspect, featured is a method of determining a predetermined threshold of a performance metric from positional data of pelvic floor exercise therapy. The method includes (a) obtaining positional data from one or more sensors of an intravaginal device during performance of a pelvic floor exercise during a first treatment phase of a first therapy. The method further includes (b) obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. The method may also include (c) processing the positional data from the one or more sensors and the survey questionnaire data to establish a predetermined threshold of the performance metric.

[0007] The positional data may include sensor angle and / or time. The performance metric may include, for example, average lift angle, average lift duration, frequency of lift, days or weeks since the subject began treatment, number of treatment sessions since the subject began treatment, or a combination thereof (e.g., a composite score that includes one or more of average lift angle, average lift duration, and frequency of lift).

[0008] The performance metric may be a composite score that includes an average lift angle and a patient acceptable symptom state (PASS) score and may be weighted by other variables, such as age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, type of pelvic floor disorder diagnosed, severity of disease, and adherence to the pelvic floor exercise regimen. The composite score may include average lift angle, average lift duration, and a PASS score. The performance metric may also include a score or weighting factor that includes of one or more of demographic, physiological or medical history data from the subject including, for example, weight, medical history, race, level of exercise, reproductive history, income level, occupation. Such data may be provided directly by the subject, a caregiver, or a medical record.

[0009] The first treatment phase may be from 1 day to 16 weeks (e.g., 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 15 days, 16 days, 17 days, 18 days, 19 days, 20 days, 21 days, 22 days, 23 days, 24 days, 25 days, 26 days, 27 days, 28 days, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, or 16 weeks). In some embodiments, the first treatment phase is from 1 to 2 weeks (e.g., 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, or 14 days).

[0010] The methods described herein include collecting performance data during this first treatment phase, and this data may be processed to compare with historical data (e.g., from a population of subjects who have previously performed the treatment) to determine a likelihood of success and / or whether an alternative treatment regimen should be considered.

[0011] The second treatment phase may be from 1 days to 1 year (e.g., 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 5 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, or 12 months. The second treatment phase may be from 1 week to 16 weeks (e.g., 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, or 16 weeks). The second treatment phase may be continued until one or more symptoms of the pelvic floor disorder are reduced or resolved. Processing the data may include using an algorithm. The processing may include using an algorithm to calculate the performance metric based on a change in sensor angle over time (e.g., average lift angle) or duration of lift by the subject. The processing may include using an algorithm to calculate the performance metric based on a composite score weighted by other variables, such as age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, type of pelvic floor disorder diagnosed, severity of disease, and treatment regimen adherence.

[0012] Processing the data may include processing data from a survey questionnaire that includes a score or question related to symptom severity, symptom improvement and / or user satisfaction. The survey questionnaire may include, for example, a Urinary Distress Inventory (UDI-6) survey and / or other assessment of whether the subject has reached a Patient Acceptable Symptom State (PASS). The survey questionnaire data may be obtained prior to the first treatment phase of the first therapy and following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. Collecting more than one data point allows one to track the change in progress of the survey questions (e.g., “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?”).

[0013] Processing the data may include processing data regarding subject adherence to the first treatment phase of the therapy. For example, if the subject does not adhere, then the data or a performance metric may be weighted by a factor corresponding to how strictly the subject adhered to the treatment regimen (e.g., 0 is noncompliant and 1 is compliant).

[0014] Processing the data may also include an analysis of one or more of demographic, physiological or medical history data from the subject including, for example, weight, medical history, race, level of exercise, reproductive history, income level, occupation. Such data may be provided directly by the subject, a caregiver, or a medical record.

[0015] In some embodiments, the performance metric varies with respect to time (e.g., the metric may increase linearly with respect to time, e.g., as the subject improves her performance). The processing may include performing a linear regression of the positional data (e.g., to determine a slope) or the duration of lift by the subject (e.g., to determine time associated with a certain lift angle or slope).

[0016] The predetermined threshold and / or the performance metric, may vary as a function of age of the subject, type of pelvic floor disorder diagnosed, and / or severity of the pelvic floor disorder. The intravaginal device may include a plurality of sensors located along a length of the device. The sensors may be microelectromechanical (MEM) accelerometers.

[0017] In some embodiments, the predetermined threshold is calculated based on performance of the first therapy by a population of subjects. The population of subjects may include at least 50 subjects (e.g., at least 60 at least 70, at least 80, at least 90, at least 100, at least 150, at least 200, at least 250, at least 300, at least 350, at least 400, at least 450, at least 500, or more subjects). For example, the population of subjects may include a first subset of the population of subjects that been determined to be responsive to the first therapy and a second subset of the population of subjects that has been determined to be nonresponsive to the first therapy. The predetermined threshold of the performance metric may include a minimum clinical important difference (MCID) or a patient acceptable symptom state (PASS) of the population. The performance metric (e.g., average lift angle or duration of lift by the subject) may vary with respect to time. For example, the performance metric (e.g., average lift angle or duration of lift by the subject) may increase linearly with respect to time, e.g., as the subject improves her performance.

[0018] The performance metric may be an average lift angle of 5 ° to 40 °, e.g., 5 ° to 30 ° (e.g., 5 °, 6 °, 7 °, 8 °, 9 °, 10 °, 11 °, 12°, 13 °, 14 °, 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39°, or 40 °). The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after one week of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after two weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after three weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after four weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after five weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after six weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after seven weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after eight weeks of the first treatment phase of the first therapy. The performance metric may continue on a week to week or other frequency as needed in connection with the subject’s therapy.

[0019] The performance metric may be a duration of time that the subject can hold a lift at a certain lift angle of 5 ° to 40 °, e.g., 5 ° to 30 ° (e.g., 5 °, 6 °, 7 °, 8 °, 9 °, 10 °, 11 °, 12°, 13 °, 14 °, 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39°, or 40 °). The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after one week of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after two weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after three weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after four weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after five weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after six weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after seven weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after eight weeks of the first treatment phase of the first therapy. The performance metric may continue on a week to week or other frequency as needed in connection with the subject’s therapy.

[0020] The first treatment phase may include a defined set of pelvic floor exercises. For example, the first treatment phase may include performing alternating pelvic floor lifts and pelvic floor relaxations. For example, the first treatment phase may include performing 15 seconds of pelvic floor lifts and 15 seconds of pelvic floor relaxations. The pelvic floor lifts and pelvic floor relaxations may be repeated one or more (e.g., 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) times. For example, the pelvic floor lifts and pelvic floor relaxations may be repeated five times for a duration of 2.5 minutes. These sessions may be repeated twice daily, e.g., the 2.5 minute sessions that include pelvic floor lifts and pelvic floor relaxations may be repeated twice daily.

[0021] The second treatment phase of the first therapy may be the same as the first treatment phase of the first therapy. Alternatively, the second treatment phase of the first therapy may be different than the first treatment phase of the first therapy. In some embodiments, the second treatment phase includes performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first treatment phase of the first therapy.

[0022] The second therapy may be different from the first therapy. The second therapy may include performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first therapy. The second therapy may include alternative treatments, such as electrical stimulation therapy, anticholinergic or beta-agonist therapy, use of an incontinence pessary, peripheral neuromodulation, tibial neuromodulation, sacral neuromodulation, periurethral bulking, an intravaginal balloon or other prosthetic, or surgical intervention (e.g., a mid-urethral sling, a rectus fascia sling, a Burch colposuspension procedure, or a Marshall Marchetti Krantz (MMK) culposuspension procedure).

[0023] In some aspects of any of the above embodiments, the method further includes (i) obtaining positional data from one or more sensors of an intravaginal device used during performance of the one or more pelvic floor lifts during the second therapy; and (ii) processing the positional data from the one or more sensors to establish a second performance metric to determine the likelihood of treatment success of the second therapy.

[0024] In some embodiments, the second performance metric is above a predetermined threshold, and the method includes continuing treatment of the pelvic floor disorder during a second treatment phase of the second therapy. In other embodiments, the second performance metric is below the predetermined threshold, and the method includes performing a third therapy that is different from the second therapy.

[0025] The methods described herein may include discontinuing treatment, e.g., when one or more symptoms of the pelvic floor disorder are reduced or resolved, e.g., following the first phase or second phase of the first therapy or following the second therapy.

[0026] The methods described herein may include a survey questionnaire, such as a UDI-6 survey. The subject may have a UDI-6 score of greater than or equal to 37.5 prior to treatment. The subject may have a UDI-6 score of less than or equal to 37.5 after treatment.

[0027] In some embodiments, the method is performed with a peripheral device. For example, the performance metric may be displayed on a peripheral device that includes a computer processing unit configured to receive and process data from the one or more sensors of the intravaginal device. The peripheral device may display a progress of the performance metric, e.g., over time. The peripheral device may include an audio and / or visual alert that provides feedback to the subject. The peripheral device may include settings for personalizing operation of the intravaginal device for the subject, e.g., relative to the performance metric.

[0028] In another aspect, featured is a peripheral device that includes a computer processing unit configured to receive data from one or more sensors of an intravaginal device. The peripheral device is configured to (a) obtain positional data from the one or more sensors of the intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and (b) process the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy. The peripheral device may further be configured to (c) direct the user to continue treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, wherein the performance metric is above a predetermined threshold; or direct the user to perform a second therapy that is different from the first therapy in the subject wherein the performance metric is below the predetermined threshold.

[0029] The peripheral device may be further configured to obtain survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., by input into the graphical user interface. The peripheral device may be further configured to process the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

[0030] The peripheral device may be, for example, a smartphone or tablet. The peripheral device may include a graphical user interface, such as a touchscreen graphical user interface. The peripheral device may be configured to perform a method as described herein, e.g., of any of the above embodiments.

[0031] In another aspect, featured is a system that includes a peripheral device as described herein, e.g. of any of the above embodiments, and the intravaginal device that includes one or more sensors (e.g., MEM accelerometers). The intravaginal device may include a plurality of sensors located along a length of the device. The peripheral device may include settings for personalizing operation of the intravaginal device for the subject, e.g., relative to the performance metric.

[0032] In another aspect, featured is a method of treatment a pelvic floor disorder by determining the likelihood of treatment success. The method includes (a) obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and (b) processing the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy. The method may further include obtaining survey questionnaire data from the subject including symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. Processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric. In some embodiments, the likelihood of treatment success is positive if the performance metric is above a predetermined threshold. In some embodiments, the likelihood of treatment success is negative if the performance metric is below the predetermined threshold. In some embodiments, the performance metric is above the predetermined threshold, and the method further includes continuing treatment during a second treatment phase of the first therapy. In some embodiments, the performance metric is below the predetermined threshold, and the method further includes performing a second therapy that is different from the first therapy.

[0033] DEFINITIONS

[0034] As used herein, the singular form “a,” “an,” and “the” includes plural references unless indicated otherwise. As used herein, the terms “about” and “approximately” mean + / - 10% of the recited value.

[0035] As used herein, the term “in proximity to” and “proximal” refers to a location near a tissue surface (e.g., about 0.01 -5 mm from, or adjacent to, the tissue surface, e.g., surrounding the cervix or vaginal cuff of a subject).

[0036] As used herein, the term “feedback” or “biofeedback” refers to information that can be used to train a subject to change physiological activity (e.g., pelvic floor muscle function) for the purpose of improving health and performance (e.g., treating, reducing, and / or preventing the occurrence of or the symptoms of a pelvic floor disorder (PFD)) . Biofeedback may also include information collected by a sensor of a device, such as an intravaginal device, during daily monitoring, e.g., in substantially real-time, while a user performs a daily activity or pelvic floor exercise. The information can be reviewed substantially in real-time or can be accessed for review later. The presentation of this information to the subject may be transmitted via a visual, audible, or tactile signal.

[0037] As used herein, the term “diagnosis” refers to the identification or classification of a disease or condition (e.g., a pelvic floor disorder). For example, “diagnosis” may refer to identification of a particular type of urinary incontinence.

[0038] A “disorder” is any condition that would benefit from treatment including, but not limited to, chronic and acute disorders or diseases, including those pathological conditions which predispose the subject to the disorder in question.

[0039] As used herein, the term “monitoring” refers to a use of an intravaginal device as described herein, to collect, track, and / or store data, e.g., data obtained from sensor(s) of a device described herein. The monitoring can occur, e.g., when the device is positioned within the body, such as within the vaginal cavity of a user and / or when the device is used during a diagnostic or treatment period.

[0040] As used herein, the terms “pelvic floor lift” and “PFL” refers to a movement of the pelvic floor (e.g., the muscle fibers of the levator ani (e.g., the pubococcygeus, ileococcygeus, coccygeus, and puborectalis muscles, as well as movement of perineal muscles and anal sphincter) and the associated connective tissues which span the area in a spherical form from the pubic bone anteriorly to the sacrum posteriorly and to the adjoining bony structure joining these two bones, which is characterized by an upward movement (e.g., a lifting movement, such as a movement in the cranial direction) of the pelvic floor. The movement of the pelvic floor during a PFL is a distinctly-described component of the collective action of the entire pelvic floor (e.g., the levator ani, urethral and anal sphincters, bulbocavernosus, ischiocavernosus, superficial transverse perineal muscles) whereby the combined lifting and circumferentially-directed squeezing action is produced when all muscles are activated simultaneously. A PFL may involve the selective engagement of the levator ani component of the pelvic floor.

[0041] As used herein, the terms “pelvic floor relaxation” and “PFR” refers to a movement of the pelvic floor (e.g., the muscle fibers of the levator ani (e.g., the pubococcygeus, iliococcygeus, coccygeus, and puborectalis muscles) and the associated connective tissues which span the area in a spherical form from the pubic bone anteriorly to the sacrum posteriorly and to the adjoining bony structure joining these two bones), which is characterized by a relaxation (e.g., a downward movement, such as a movement in the caudal direction) of the pelvic floor. The movement of the pelvic floor during a PFR is distinct from the concentric contraction (e.g., shortening contraction) of the PFL, and represents the lengthening or relaxation of the muscle fibers. As used herein, “real-time” refers to the actual time during which an event, such as a daily activity, occurs.

[0042] As used herein, “sensor data” refers to a measurement (e.g., any one or more of measurements of muscle (e.g., pelvic floor muscle) movement, muscle quality, muscle strength, pressure, and measurements of other conditions, such as pH, temperature, and / or moisture (e.g., in the vagina)), which characterize a subject’s pelvic floor health and are obtained by a sensor(s), as described herein, of an intravaginal device described herein. Sensor data may also be collected that relate to a pelvic floor movement to, e.g., urinary or fecal incontinence or urge. These data can be used, e.g., to diagnose and / or treat urinary incontinence and / or fecal incontinence.

[0043] As used herein, “radio frequency” refers to electromagnetic waves that have a frequency in the range from 103Hz to 1012Hz.

[0044] As used herein, the terms “subject” and “patient” may be used interchangeably to refer to a mammal, such as a human.

[0045] As used herein, the terms “reducing” and “inhibiting” are defined as the ability to cause an overall decrease of about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, or more in a measurable metric. Reduce or inhibit can refer, for example, to the symptoms of the pelvic floor disorder (PFD) being treated.

[0046] As used herein, the term “survey questionnaire” refers to a set of one or more questions asked of a user regarding the state or severity of their pelvic floor disorder (e.g., the state or severity of their symptoms or the state of their symptom improvement). The questions may include a yes or no answer or may ask the user to rate a symptom or result on a relative scale (e.g., 0 to 5 or 0 to 10). The survey questionnaire may include, for example, a Urinary Distress Inventory (UDI-6) survey and / or other assessment of whether the subject has reached a Patient Acceptable Symptom State (PASS). The PASS may be based on the level of a subject’s symptoms according to a symptom scale (e.g., the scale used in the UDI-6 survey) or could include the survey question “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?”). The PASS is a threshold score beneath which a patient considers herself well and is likely to no longer pursue / require treatment. Patients may be considered to have achieved PASS if they have reached a certain level on a symptom scale and / or if they responded “yes” to the survey question “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?”. The UDI-6 survey is described, e.g., in Skorupska et al. {Health Qual Life Outcomes 19:87, 2021 ). The UDI-6 consists of 6 items: 1 -Frequent urination, 2-Leakage related to feeling of urgency, 3-Leakage related to activity, 4- Coughing, or sneezing small amounts of leakage (drops), 5-Difficulty emptying the bladder, and 6-Pain or discomfort in the lower abdominal or genital area. Higher scores in UDI-6 indicate higher disability, and the total score is from 0 to 100.

[0047] As used herein, the term “treating” refers to providing a therapy to a subject in need thereof (e.g., to treat or reduce the likelihood of urinary or fecal incontinence, or urge associated therewith), in particular in conjunction with the use of an intravaginal device, system, or method described herein. To “treat disease” or use for “therapeutic treatment” includes administering treatment to a subject already suffering from a disease to improve or stabilize the subject’s condition. To “prevent” or “reduce the likelihood of developing” disease refers to prophylactic treatment of a subject who is not yet ill or symptomatic, but who is susceptible to, or otherwise at risk of, a particular disease, such as a urinary or fecal incontinence or pelvic organ prolapse.

[0048] As used herein, “female urogenital system” refers to the organ system of the female reproductive system, which includes, e.g., the Bartholin's glands, cervix, clitoris, clitoral frenulum, clitoral glans (glans clitoridis), clitoral hood, fallopian tubes, labia, labia majora, labia minora, frenulum of labia minora, ovaries, skene's gland, uterus, vagina, and vulva; the urinary system, which includes, e.g., the kidneys, ureters, bladder, and the urethra; and the surrounding and supporting nerves and musculature.

[0049] As used herein, “vaginal cuff” refers to the sutured tissue at the top of the vaginal canal remaining after removal of the cervix (e.g., during a hysterectomy).

[0050] As used herein, “urinary incontinence” refers to the leaking of urine from the bladder. Incontinence can range from leaking just a few drops of urine to complete emptying of the bladder. Urinary incontinence can be divided into three main types: stress urinary incontinence (SUI), urgency urinary incontinence, and mixed incontinence. Stress urinary incontinence is leaking urine when coughing, laughing, or sneezing. Leaks can also happen when a subject (e.g., female subject) walks, runs, or exercises. Urgency urinary incontinence is a sudden strong urge to urinate that is hard to stop. Women with this type of urinary incontinence may leak urine on the way to the bathroom. Mixed incontinence combines symptoms of both stress and urgency urinary incontinence.

[0051] As used herein, “pelvic floor” refers to the muscular area at the base of the abdomen attached to the pelvis.

[0052] As used herein, “pelvic floor disorders” or “PFDs” refers to disorders affecting the muscles and tissues that support the pelvic organs. These disorders may result in loss of control of the bladder or bowels or may cause one or more pelvic organs to drop downward, resulting in prolapse.

[0053] DESCRIPTION OF THE DRAWINGS

[0054] FIG. 1 is a graph showing progress of pelvic floor lift exercises over time. The graph depicts average lift angle as a function of time, shown in both days and weeks. Average lift angle data was collected for 880 subjects, who were stratified into two groups, corresponding to (1 ) those who reported reaching a minimum clinical important difference and / or having reached a patient acceptable symptom state (PASS+) (2) those who reported not having reached a minimum clinical important difference and / or not having reached a patient acceptable symptom state (PASS-). Two curves are depicted, illustrating the average lift angle over time for the two groups. These trend lines are then used to determine a likelihood of treatment success and / or whether an alternative treatment regimen may be appropriate by correlating the subject’s performance with one of the trend lines as well as other variables, such as age, type of pelvic floor disorder diagnosed, baseline disease severity, and hold time.

[0055] FIG. 2 is a schematic drawing showing how an algorithm for predicting treatment success can be optimized over time as more data is input into the model.

[0056] FIG. 3 is a set of variables associated with a predictive model. Commercial Data for a large cohort of women with urinary incontinence (-950) Outcomes. This graph illustrates variables associated with successful treatment and how likelihood of success can be predicted after 2-weeks of use of an intravaginal device. FIG. 4 is a graph showing how likelihood of success can increase with initial non responders by increasing compliance.

[0057] DETAILED DESCRIPTION

[0058] Described herein are methods for treating pelvic floor disorders (e.g., urinary incontinence) and monitoring pelvic floor treatment therapy. Also featured herein are methods for determining a likelihood of success of a pelvic floor therapy that allows a user or health care provider to monitor treatment efficacy and adjust therapeutic methods as needed to ensure optimized treatment outcomes.

[0059] In general, the methods described herein employ performance of pelvic floor exercise therapy that includes one or more pelvic floor maneuvers (e.g., lift maneuvers) that are used to strengthen the musculature of the pelvic floor. The pelvic floor exercises may include using an intravaginal device that contains one more position or movement sensors (e.g., microelectromechanical (MEM) accelerometers) that may be disposed along a length of the device. These sensors (e.g., accelerometers) provide realtime position and movement data that can be used to track the position of the device within the vagina of a subject. Movement of the device, as detected by the accelerometers, acts as a proxy to determine the position of the pelvic floor muscles of the subject during a pelvic floor exercise.

[0060] The sensor output of one or more accelerometers reflects a vaginal angle position, and this angle generally correlates with the strength of the lift maneuver. Thus, a higher lift angle corresponds with an increased lift, which is desirable to increase the strength of the pelvic floor muscles, to thereby treat a pelvic floor disorder. Sensor angle data produced by accelerometers of an intravaginal device are described, e.g., in PCT Pub. Nos. WO / 2015 / 103629 and WO / 2019 / 200222, the disclosures of which are hereby incorporated by reference in their entirety.

[0061] The performance of pelvic floor exercise therapy is effective to treat a variety of pelvic floor disorders in many subjects. However, a subset of subjects is nonresponsive to pelvic floor exercise therapy or may need an alternative treatment that includes modified pelvic floor muscle therapy. Thus, pelvic floor exercise therapy for such nonresponsive subjects may be undesirable or unnecessary as it is not likely to produce any clinically meaningful change in their disease state. Alternatively, pelvic floor exercise therapy for such nonresponsive subjects may need to be modified in order for it to produce any clinically meaningful change in their disease state. Accordingly, the present methods reflect the discovery that a user can be tracked over time during an initial phase of their pelvic floor exercise therapy while using an intravaginal device with one or more positional sensors. As the user performs pelvic floor exercises, a performance metric can be calculated based on one or more physiological indicia produced from the sensors, such as average lift angle or duration of lift by the subject. As the performance metric is tracked over time, an algorithm may be used to determine the likelihood of success of the pelvic floor exercise therapy and / or whether an alternative treatment regimen should be considered. If the subject is likely to be treated with pelvic floor exercises, the user can continue pelvic floor exercises using the intravaginal device or may alter their exercise protocol to improve strength and performance. Alternatively, if the therapy is determined to be unlikely to result in a clinically meaningful change in their disease state, then the pelvic floor exercise therapy may be terminated and an alternative therapy can be employed. By determining the likelihood of success early in the treatment regimen, the methods described herein reduce wasted time in pursuing a therapy that is unlikely to succeed while optimizing treatment protocols for users who demonstrate meaningful clinical benefits using pelvic floor exercise therapy without resorting to unnecessary or more invasive treatment options, such as surgery.

[0062] Establishing a Performance Metric

[0063] The methods described herein include collecting data, such as positional data and / or questionnaire data to establish a performance metric. The methods may include obtaining positional data from one or more sensors of an intravaginal device, e.g., when the device is used during performance of one or more pelvic floor exercises (e.g., pelvic floor lifts) during a data collection phase. The data collection phase may be from 1 day to 16 weeks (e.g., 1 day to 12 weeks, e.g., 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 15 days, 16 days, 17 days, 18 days, 19 days, 20 days, 21 days, 22 days, 23 days, 24 days, 25 days, 26 days, 27 days, 28 days, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, or 16 weeks). In some embodiments, the data collection phase is from 1 to 2 weeks (e.g., 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, or 14 days).

[0064] The positional data obtained by the methods described herein may include sensor angle and / or time. The performance metric may be a function of or correlate with this sensor angle and time. For example, the performance metric may include one or more of average lift angle, average lift duration, frequency of lift, or a combination thereof (e.g., a composite score that includes one or more of average lift angle, average lift duration, and frequency of lift). The intravaginal device may include a plurality of sensors (e.g., microelectromechanical (MEM) accelerometers) located along a length of the device, and the sensor angle data may be obtained from these accelerometers. The performance metric may also include a score or weighting factor that includes of one or more of demographic, physiological or medical history data from the subject including, for example, weight, medical history, race, level of exercise, reproductive history, income level, occupation. Such data may be provided directly by the subject, a caregiver, or a medical record.

[0065] The method may further include obtaining survey questionnaire data from the subject including symptom severity, symptom improvement and / or user satisfaction following at least a portion of the data collection phase, e.g., following performance of at least one day (e.g., at least one week) of pelvic floor exercise treatment.

[0066] The survey questionnaire may include, for example, a Urinary Distress Inventory (UDI-6) survey and / or other assessment of whether the subject has reached a Patient Acceptable Symptom State (PASS). The survey questionnaire data may be obtained prior to the data collection phase and following performance of at least one day of pelvic floor exercise treatment. Collecting more than one data point allows one to track the change in progress of the survey questions (e.g., “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?”). The PASS is the threshold score beneath which a patient considers herself well and is likely to no longer pursue / require treatment. Patients may be considered to have achieved PASS if they have reached a certain level on a symptom scale and / or if they responded “yes” to the survey question “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?”.

[0067] The methods described herein include establishing a performance metric by combining physical data (e.g., objective data) and survey data (e.g., subjective data) and processing the data to produce, for example, a composite score. The processing step may include processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric. The performance metric may be a composite score that includes an average lift angle and a PASS or other symptom assessment score and may be weighted by or combined with other variables, such as age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, type of pelvic floor disorder diagnosed, severity of disease, and adherence to the pelvic floor exercise regimen. The composite score may include, for example, average lift angle, average lift duration, and a PASS or other symptom assessment score. Once this data is collected, it may be compared to a predetermined threshold of the performance metric to establish a likelihood of success. For example, the performance metric may be compared with historical data (e.g., from a population of subjects who have previously performed the treatment) to determine a likelihood of success.

[0068] If the subject reaches a certain composite score and / or reaches a certain lift angle and / or duration of lift, then that may strongly correlate with a positive treatment outcome. Furthermore, the progression of pelvic floor exercises to consistently perform an average lift angle indicative of a healthy or treated subject or on a trend line consistent with the achievement of such an outcome, that that will strongly factor into determining a likelihood of success of the pelvic floor therapy and / or whether an alternative treatment regimen should be considered. Alternatively, if the subject cannot reach a certain composite score and / or their average pelvic floor lift angles are consistently performed below average or on a trend line consistent with those who do not achieve positive treatment outcomes, then this may indicate an unlikelihood of success of the pelvic floor therapy.

[0069] As shown in FIG. 2, an algorithm can be optimized over time as more data is input into a model. Multiple factors are weighted based on their degree of association with the outcome (+ / - PASS). This is based on the type of regression analysis used (e.g., logistic regression, random forest, k-means) which is then used in a supervised machine learning protocol. The algorithm described herein included a regression that involved both linear and logistic regression. Once an initial analysis of historic data is performed, the model is trained (enhanced / honed) and tested using additional existing data. This tests the model’s predictive ability on new data that was not used to create the initial model. Once the model has been optimized for sensitivity and or specificity, it can then be used to predict outcomes for new patients on an individual level. The selection of the degree of sensitivity and specificity (false negatives or positives) is determined based on the use of the model. For example, if one were to use the model to influence coaching, one would be interested in minimizing the number of false positives. If one were to use the model as a precursor to surgery, eliminating false negatives would be the focus.

[0070] The weighting may be determined by the analysis of a historical data set, trained, and validated on a new data set, and then applied to individuals. Weighting may be determined by a regression analysis that arrives at the best “fit” for all the variables, to provide a regression model that is most predictive. Exemplary weighting curves and variables are shown in FIG. 3 and Tables 1 and 2. FIG. 4 shows how the likelihood of success can increase based on increased compliance. Methods of Treatment

[0071] The methods described herein employ a performance metric as described above. For example, featured herein is a method of treating a pelvic floor disorder by determining the likelihood of treatment success. The method includes the step of obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor exercises during a first treatment phase of a first therapy. The method may further include processing the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy. The likelihood of treatment success may be positive or negative. The method may further include obtaining survey questionnaire data from the subject including symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. The processing step may include processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric. The likelihood of treatment success may be positive if the performance metric is above a predetermined threshold. Alternatively, the likelihood of treatment success is negative if the performance metric is below the predetermined threshold. If the performance metric is above the predetermined threshold, the method may further include continuing treatment, e.g., during a second treatment phase of the first therapy. If the performance metric is below the predetermined threshold, the method may further include performing a second therapy that is different from the first therapy. The methods described herein include collecting performance data during this first treatment phase, and this data may be processed to compare with historical data (e.g., from a population of subjects who have previously performed the treatment) to determine a likelihood of success and / or whether an alternative treatment regimen should be considered. The performance metric may be a composite score that includes an average lift angle and a symptom assessment score and may be weighted by other variables, such as age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, severity of disease, and adherence to the pelvic floor exercise regimen. The composite score may include average lift angle, average lift duration, and a symptom assessment score.

[0072] Also featured is a method of determining a predetermined threshold of a performance metric from positional data of pelvic floor exercise therapy. The method includes obtaining positional data from one or more sensors of an intravaginal device during performance of a pelvic floor exercise during a first treatment phase of a first therapy. The method further includes obtaining survey questionnaire data from the subject with respect to symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. The method may also include processing the positional data from the one or more sensors and the survey questionnaire data to establish a predetermined threshold of the performance metric.

[0073] The positional data obtained by the methods described herein may include sensor angle and / or time. The performance metric may be a function of or correlate with this sensor angle and time. For example, the performance metric may include one or more of average lift angle, average lift duration, frequency of lift, or a combination thereof (e.g., a composite score that includes one or more of average lift angle, average lift duration, and frequency of lift). The intravaginal device may include a plurality of sensors (e.g., microelectromechanical (MEM) accelerometers) located along a length of the device, and the sensor angle data may be obtained from these accelerometers.

[0074] Processing the data may include processing data from a survey questionnaire that includes a score or question related to symptom severity, symptom improvement and / or user satisfaction. The survey questionnaire may include, for example, a Urinary Distress Inventory (UDI-6) survey and / or other assessment of whether the subject has reached a Patient Acceptable Symptom State (PASS). The survey questionnaire data may be obtained prior to the first treatment phase of the first therapy and following at least a portion of the first treatment phase, e.g., following performance of at least one day of pelvic floor exercise treatment. Collecting more than one data point allows one to track the change in progress of the survey questions (e.g., “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?”). The PASS is the threshold score beneath which a patient considers herself well and is likely to no longer pursue / require treatment. Patients may be considered to have achieved PASS if they have reached a certain level on a symptom scale and / or if they responded “yes” to this question. The UDI-6 survey is described, e.g., in Skorupska et al. (Health Qual Life Outcomes 19:87, 2021 ), which is incorporated herein by reference. The Patient Acceptable Symptom State (PASS) scale of female urinary incontinence was used as a subjective measure of patient treatment (see, e.g., Sanderson et al. Female Pelvic Medicine and Reconstrunctive Surgery 28:1 , 33-39, 2021 ), which is incorporated herein by reference. The subject may have a UDI-6 score of greater than or equal to 37.5 prior to treatment. The subject may have a UDI-6 score of less than or equal to 37.5 after treatment.

[0075] Processing the data may include processing data regarding subject adherence to the first treatment phase of the therapy. For example, if the subject does not adhere, then the data or a performance metric may be weighted by a factor corresponding to how strictly the subject adhered to the treatment regimen (e.g., 0 is noncompliant and 1 is compliant). The performance metric may vary with respect to time (e.g., the metric may increase linearly with respect to time, e.g., as the subject improves her performance). The processing may include performing a linear regression of the positional data (e.g., to determine a slope) or the duration of lift by the subject (e.g., to determine time associated with a certain lift angle or slope). The predetermined threshold and / or the performance metric may vary as a function of age of the subject, type of pelvic floor disorder diagnosed, and / or severity of the pelvic floor disorder. Processing the data may also include an analysis of one or more of demographic, physiological or medical history data from the subject including, for example, weight, medical history, race, level of exercise, reproductive history, income level, occupation. Such data may be provided directly by the subject, a caregiver, or a medical record.

[0076] The methods described herein include treating a pelvic floor disorder in a subject. The method may include the step of obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor exercises during a first treatment phase of a first therapy. This method may further include processing the positional data from the one or more sensors to establish a performance metric. The method may further include continuing treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, e.g., wherein the performance metric is above a predetermined threshold. Alternatively, the method may include performing a second therapy that is different from the first therapy in the subject, e.g., wherein the performance metric is below the predetermined threshold.

[0077] Other methods contemplated herein include treating a pelvic floor disorder in a subject nonresponsive to a first therapy, e.g., a first therapy that includes pelvic floor exercises. The method may include treating the subject with a second therapy that is different from the first therapy. The subject may have previously been determined to be nonresponsive to the first therapy by obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor exercises during a first treatment phase of the first therapy and processing the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy. The subject may have been determined to be nonresponsive by a determination that the performance metric was below a predetermined threshold.

[0078] The positional data obtained by the methods described herein may include sensor angle and / or time. The performance metric may include, for example, average lift angle, average lift duration, frequency of lift, or a combination thereof (e.g., a composite score that includes one or more of average lift angle, average lift duration, and frequency of lift).

[0079] The first treatment phase may be from 1 day to 16 weeks (e.g., 1 day to 12 weeks, e.g., 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 15 days, 16 days, 17 days, 18 days, 19 days, 20 days, 21 days, 22 days, 23 days, 24 days, 25 days, 26 days, 27 days, 28 days, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, or 16 weeks). In some embodiments, the first treatment phase is from 1 to 2 weeks (e.g., 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, or 14 days). Data collection may occur during all or a portion of a term of the first treatment phase (e.g., data collection may occur multiple times per day, once per day, one or more times every other day, one or more times every third day, one or more times once a week, etc.).

[0080] The methods described herein include collecting performance data during this first treatment phase, and this data may be processed to compare with historical data (e.g., from a population of subjects who have previously performed the treatment) to determine a likelihood of success and / or whether an alternative treatment regimen should be considered.

[0081] The second treatment phase may be from 1 days to 1 year (e.g., 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 5 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, or 12 months. The second treatment phase may be from 1 week to 16 weeks (e.g., 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, or 16 weeks). The second treatment phase may be continued until one or more symptoms of the pelvic floor disorder are reduced or resolved.

[0082] As shown in FIG. 1 , the progress of pelvic floor lift exercises, as measured by average lift angle, gradually increases over time. When a subject typically begins pelvic floor exercise therapy, she exhibits an initial burst in an initial learning phase. Then, the increase in average lift angle continues to increase linearly but with a smaller slope . Eventually, the progress of the user will likely plateau as they approach a maximum average lift angle. As discussed in Example 1 and summarized in FIG. 1 , average lift angle data as a function of time, shown in both days and weeks, was collected for 880 subjects. These subjects were stratified into two groups, corresponding to (1 ) those exhibiting who reported reaching a minimum clinical important difference and / or having reached a patient acceptable symptom state (PASS+) or (2) those who reported not having reached a minimum clinical important difference and / or not having reached a patient acceptable symptom state (PASS-). Two curves are depicted, illustrating the average lift angle over time for the two groups. These trend lines are then used to determine a likelihood of success by correlating the subject’s performance with one of the trend lines, as well as other variables, such as age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, type of pelvic floor disorder diagnosed, baseline disease severity, and hold time.

[0083] Processing the data may include using an algorithm. The processing may include using an algorithm to calculate the performance metric based on a change in sensor angle over time or average lift angle as well as subjective questionnaire data, such as if the user determines that the pelvic floor symptoms are at an acceptable state. Such processing may occur in the intravaginal device, within a peripheral device used in conjunction with the intravaginal device, on a separate computer, or in a cloud. The processing may also include processing the survey questionnaire data. The performance metric may be a composite score that includes an average lift angle and a patient acceptable symptom state.

[0084] In some embodiments, the predetermined threshold is calculated based on performance of the first therapy by a population of subjects. The population of subjects may include at least 50 subjects (e.g., at least 60 at least 70, at least 80, at least 90, at least 100, at least 150, at least 200, at least 250, at least 300, at least 350, at least 400, at least 450, at least 500, or more subjects). For example, the population of subjects may include a first subset of the population of subjects that been determined to be responsive to the first therapy and a second subset of the population of subjects that has been determined to be nonresponsive to the first therapy. The predetermined threshold of the performance metric may include a minimum clinical important difference (MCID) or a patient acceptable symptom state (PASS) of the population.

[0085] Both MCID and PASS are calculated values derived from psychometric evaluations of hundreds of women who have used the UDI-6 surveys. Both MCID and PASS are values / thresholds. The MCID may be calculated by subtracting the last reported value from the baseline value, to determine if the extent of survey change is likely to correspond to clinical or experiential change. The PASS is calculated as the value beneath which a patient is likely to consider herself well and not pursue further treatment. The subject may have a UDI-6 score of greater than or equal to 37.5 prior to treatment. The subject may have a UDI-6 score of less than or equal to 37.5 after treatment.

[0086] The performance metric (e.g., average lift angle or duration of lift by the subject) may vary with respect to time. For example, the performance metric (e.g., average lift angle or duration of lift by the subject) may increase linearly with respect to time, e.g., as the subject improves her performance.

[0087] The performance metric may be an average lift angle of 5 ° to 40 °, e.g., 5 ° to 30 ° (e.g., 5 °, 6 °, 7 °, 8 °, 9 °, 10 °, 11 °, 12°, 13 °, 14 °, 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39°, or 40 °). The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after one week of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after two weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after three weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after four weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after five weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after six weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after seven weeks of the first treatment phase of the first therapy. The performance metric may be an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after eight weeks of the first treatment phase of the first therapy. The performance metric may continue on a week to week or other frequency as needed in connection with the subject’s therapy.

[0088] The performance metric may be a duration of time that the subject can hold a lift at a certain lift angle of 5 ° to 40 °, e.g., 5 ° to 30 ° (e.g., 5 °, 6 °, 7 °, 8 °, 9 °, 10 °, 11 °, 12°, 13 °, 14 °, 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39°, or 40 °). The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after one week of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after two weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after three weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after four weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after five weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after six weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after seven weeks of the first treatment phase of the first therapy. The performance metric may be a duration of time for an average lift angle of 5 ° to 40 ° (e.g., 5 ° to 30 °) after eight weeks of the first treatment phase of the first therapy. The performance metric may continue on a week to week or other frequency as needed in connection with the subject’s therapy. The first treatment phase may include a defined set of pelvic floor exercises. For example, the first treatment phase may include performing alternating pelvic floor lifts and pelvic floor relaxations. For example, the first treatment phase may include performing 15 seconds of pelvic floor lifts and 15 seconds of pelvic floor relaxations. The pelvic floor lifts and pelvic floor relaxations may be repeated one or more (e.g., 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) times. For example, the pelvic floor lifts and pelvic floor relaxations may be repeated five times for a duration of 2.5 minutes. These sessions may be repeated twice daily, e.g., the 2.5-minute sessions that include pelvic floor lifts and pelvic floor relaxations may be performed twice daily. The data may be graphically or computationally analyzed over time in order to correlate the performance metric with the predetermined threshold, e.g., by performing a linear regression to establish a trend line of projected performance.

[0089] In one embodiment, a linear regression is performed between two trend lines corresponding to average lift angle for PASS(+) or PASS(-) based on a population of subjects. The linear regression may produce the following equations: PASS (+) y=7.22 + 2.85 * log(x) PASS (-) y=7.82 + 1 .97 * log(x)

[0090] The PASS(+) trend line has a higher y-intercept and a higher slope than the PASS(-) trend line, indicative of more meaningful change in average pelvic floor lift angle over the course of treatment. Thus, a data point for a subject falling above the PASS(-) curve could be expected to produce a likelihood of success for pelvic floor treatment therapy. In contrast, a data point following below the PASS(-) trend line could be expected to produce an unlikelihood of success for pelvic floor treatment therapy. The trend line may be used to establish a baseline by which a subject can be evaluated according to the methods described herein. In particular, the trend line can be used to establish a performance metric above which the subject is determined to be improving or successfully responding to the treatment regimen and below which the subject may be determined to be non-responsive or poorly responsive to the treatment regimen. A subject determined to be non-response or poorly responsive may be selected for more intense therapy pursuant to the first treatment regimen or may be selected for treatment according to a second treatment regimen (e.g., one that is different from the first treatment regimen). This subject may be re-enrolled in a subsequent treatment regimen (similar to or the same as that of the first treatment regimen) after successfully completing the second treatment regimen. The subject can again be assessed for their responsiveness to treatment by comparison with the trend line to determine whether the subject is successfully responding to treatment. If not, a more aggressive treatment regimen may be needed (e.g., surgery).

[0091] The second treatment phase of the first therapy may be the same as the first treatment phase of the first therapy. Alternatively, the second treatment phase of the first therapy may be different than the first treatment phase of the first therapy. In some embodiments, the second treatment phase includes performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first treatment phase of the first therapy. For example, the pelvic floor lifts may be performed with a longer hold time or in more rapid intervals, or during more frequent exercise sessions during the day. Following this adjustment in therapy, the performance metric may continue to be monitored to determine a likelihood of success of the modified therapy.

[0092] The second therapy may be different from the first therapy. The second therapy may include performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first therapy. If pelvic floor exercise therapy is not an effective treatment option, then the second therapy may include alternative treatments, such as electrical stimulation therapy, anticholinergic or beta-agonist therapy, use of an incontinence pessary, peripheral neuromodulation, tibial neuromodulation, sacral neuromodulation, periurethral bulking, an intravaginal balloon or other prosthetic, or surgical intervention (e.g., a mid-urethral sling, a rectus fascia sling, a Burch colposuspension procedure, or a Marshall Marchetti Krantz (MMK) culposuspension procedure).

[0093] The methods described herein may further include determining a performance metric during a second therapy or a second phase of the first therapy. For example, the method may further include (i) obtaining positional data from one or more sensors of an intravaginal device used during performance of the one or more pelvic floor lifts during the second therapy; and (ii) processing the positional data from the one or more sensors to establish a second performance metric to determine the likelihood of treatment success of the second therapy.

[0094] If the second performance metric is above a predetermined threshold, the method may include continuing treatment of the pelvic floor disorder during a second treatment phase of the second therapy. In other embodiments, the second performance metric is below the predetermined threshold, and the method includes performing a third therapy that is different from the second therapy.

[0095] The methods described herein may also include discontinuing treatment, e.g., when one or more symptoms of the pelvic floor disorder are reduced or resolved.

[0096] Any of the methods described herein may be performed with a peripheral device, e.g., that functions in conjunction with the intravaginal device to monitor and track treatment progress. For example, the performance metric may be displayed on a peripheral device that includes a computer processing unit configured to receive and process data from the one or more sensors of the intravaginal device. The peripheral device may display a progress of the performance metric, e.g., over time. The peripheral device may include an audio and / or visual alert that provides feedback to the subject. The peripheral device may include settings for personalizing operation of the intravaginal device for the subject, e.g., relative to the performance metric.

[0097] Peripheral Device

[0098] The systems and methods described herein may employ a peripheral device. The peripheral device may be any suitable electronic device, such as a computer, smartphone, tablet, or smart watch. The peripheral device may be programmed with a software or mobile application to facilitate use in conjunction with the devices and systems described herein. The peripheral device may be configured with a processing unit that can transform or utilize sensor data received from the intravaginal device. For example, the sensor data may be received when a subject performs a pelvic floor exercise, such as during a daily activity (e.g., activity that alters (e.g., increases and / or decreases) the overall health of her urogenital system and / or pelvic floor), to provide feedback to the subject regarding whether the detected activity affects her health status or is indicative of treatment of, or a need for treatment for, a pelvic floor disorder, such as urinary and / or fecal incontinence.

[0099] The peripheral device may include a computer processing unit configured to receive data from one or more sensors of the intravaginal device. The peripheral device may be configured to obtain positional data from the one or more sensors of the intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy. The peripheral device may be configured to process the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy. The peripheral device may further be configured to direct the user to continue treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, wherein the performance metric is above a predetermined threshold; or direct the user to perform a second therapy that is different from the first therapy in the subject wherein the performance metric is below the predetermined threshold.

[0100] The peripheral device may be further configured to obtain survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase, e.g., by input into the graphical user interface. The peripheral device may be further configured to process the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric. The peripheral device may be, for example, a smartphone or tablet. The peripheral device may include a graphical user interface, such as a touchscreen graphical user interface. The peripheral device may be configured to perform a method as described herein, e.g., of any of the above embodiments.

[0101] The peripheral device may be part of a system that includes a peripheral device as described herein and the intravaginal device that includes one or more sensors (e.g., MEM accelerometers, e.g., located along a length of the device. The peripheral device may include settings for personalizing operation of the intravaginal device for the subject, e.g., relative to the performance metric.

[0102] The peripheral device can process the sensor data to produce a baseline that can be used for comparison to sensor data obtained at a future time to provide feedback to the subject (e.g., an alert) regarding whether activities she performs are beneficial or detrimental to her health status or whether the pelvic floor movements are indicative of treatment of, or a need for treatment for a pelvic floor disorder. In addition, or alternatively, the peripheral device can process the sensor data and compare the result to a previously established or predetermined baseline (e.g., based on the subject’s previous performance or an average of a population of subjects) and based on the comparison can provide feedback to the subject (e.g., an alert) regarding whether activities performed are beneficial or detrimental to her health status or whether the pelvic floor movements are indicative of treatment of, or a need for treatment for a pelvic floor disorder. Additionally, the peripheral device can include a user interface. The user interface can be programmed to display data and / or to provide instructions for use of the intravaginal device.

[0103] The peripheral device may be equipped with a Wi-Fi or internet connection. For example, the peripheral device may be able to transmit the data from the sensors to a cloud-based, web-based, server, or other information storage regime.

[0104] The peripheral device may be configured to receive sensor data from the intravaginal device to monitor (e.g., with one or more sensors as described herein) the overall health status of a user, including the user’s urogenital system and pelvic floor (e.g., the muscle fibers of the levator ani (e.g., the pubococcygeus, ileococcygeus, coccygeus, puborectalis muscles and associated connective tissues) in substantially real-time, e.g., while a user performs her daily activities. For example, an intravaginal device may be configured to detect when a user performs a daily activity that alters (e.g., increases and / or decreases) the overall health of her urogenital system and / or pelvic floor and may provide feedback to the user, e.g., on how the detected activity affects her health status (e.g., based on average lift angle or duration of lift by the subject). Alternatively, the peripheral device may be configured with a processing unit that can transform or utilize sensor data received from the intravaginal device when a user performs a daily activity to provide feedback to the user (or a health care provider) regarding whether the detected activity affects her health status. For example, the peripheral device can process the sensor data to produce a baseline that can be used for comparison to sensor data obtained at a future time to provide feedback to the user (e.g., an alert) regarding whether an event (e.g., activities she performs during her daily routine, such as a pelvic floor movement) is beneficial or detrimental to her health status.

[0105] In addition, or alternatively, the peripheral device can process the sensor data and compare the result to a previously established or predetermined baseline and based on the comparison can provide feedback to the user (e.g., an alert) regarding whether an event (e.g., activities she performs during her daily routine, such as a pelvic floor movement) is beneficial or detrimental to her health status. A user may review the feedback in substantially real-time (e.g., the user may receive an alert noting her health status or a change in her health status) or she may review feedback at a later time of her choosing, e.g., by accessing feedback stored in the memory of the intravaginal device, in the memory of a peripheral device (e.g., a computer, phone (e.g., as an alert, an email, or a text message), or tablet that is or can be connected to the intravaginal device), and / or in the memory of a remote electronic device (e.g., a web- located and / or cloud-based database connected to the intravaginal device).

[0106] Feedback may be presented as a summary, e.g., as one or more graphs, showing how a user’s daily activities and muscle movement (e.g., a PFL and / or a PFR), muscle quality, or muscle strength, e.g., as a function of average lift angle or duration of lift by the subject. Daily monitoring, as described herein, may help a user to optimize treatment to avoid the development and / or reoccurrence of a PFD, or the symptoms thereof, and / or to inform a user on the development and / or progression and / or treatment status of an additional condition or disorder of the female pelvic floor or urogenital tract.

[0107] Pelvic Floor Exercises

[0108] The pelvic floor (PF), also referred to as the pelvic floor diaphragm, is predominantly formed by the muscle fibers of the levator ani (e.g., the pubococcygeus, ileococcygeus, coccygeus, and puborectalis muscles) and the associated connective tissues which span the area underneath the pelvis (Bharucha. Neurogastroenterol Motil. 18:507-519, 2006). The pelvic floor lift (PFL) is an exercise characterized by an upward movement (e.g., a lifting movement, e.g., a movement in the cranial direction) of the pelvic floor. A closely related movement comprising a relaxation (e.g., a downward movement, e.g., a movement in the caudal direction) of the pelvic floor is a pelvic floor relaxation (PFR). The movement of the pelvic floor during the performance of a PFL and / or a PFR may be distinct from the movement of the pelvic floor during the performance of a Kegel exercise. The Kegel movement, developed by Dr. Arnold Kegel, may be described as a contraction of the vaginal channel diameter (e.g., a squeezing movement of the vaginal walls, e.g., a movement of the vaginal walls in the dorsal-ventral or anterior-posterior) direction). During a PFL and a PFR the pelvic floor may be described as raising and lowering, respectively, the vaginal canal. This raising or lowering of the vaginal canal during a PFL and PFR may be due to the lifting and relaxing of the pelvic floor muscles.

[0109] Proper performance (e.g., accurate execution) of a PFL and / or PFR can be used to prevent injury to the pelvic floor during pelvic floor muscle training (PFMT). An individual contracting the pelvic floor muscles, such as by improperly performing a Kegel movement, may strain, damage, or otherwise reduce the effectiveness of PFMT with PFLs and / or PFRs. In particular, patients that bear down can create strain that can promote further damage to the pelvic floor. Therefore, to achieve maximum therapeutic benefit and to increase the efficacy of PFMT with PFLs and / or PFRs an intravaginal device of the invention, configured to sense and provide feedback on the accurate performance of a PFL and / or PFR, can be used along with PFLs and / or PFRs training as a therapeutic or prophylactic treatment for a PFD (e.g., to reduce the occurrence and / or severity of at least one symptom of a PFD).

[0110] A PFL and / or PFR can be identified and measured by an intravaginal device as described herein, which places a sensor within the vaginal cavity of an individual, e.g., at a location proximal to the cervix or vaginal cuff. The sensor positioned at a location proximal to the cervix or a vaginal cuff is configured to detect movement of the pelvic floor in the cranial-caudal direction (e.g., lifting and / or relaxation movements of the PF) to detect (e.g., to measure) the performance and quality of a PFL and / or PFR performed by a subject.

[0111] Intravaginal Device

[0112] The intravaginal device used in the systems and methods described herein may be an intravaginal device that contains one or more sensors (e.g., position or movement sensors). The intravaginal device may have an elongate shape (e.g., linear or cylindrical configuration) configured to fit within a female subject’s vagina. The device may have a shape that includes a ring-shaped main body and a tether that extends from the main body. The intravaginal device may be used as part of a system for monitoring pelvic floor movements during, before, or after a daily activity or during a diagnostic procedure. The device can be inserted into the vagina of a female subject, such that the intravaginal device is positioned proximal to the cervix or vaginal cuff. The intravaginal device may contain one or more position or movement sensors (e.g., MEMS accelerometers) and / or other sensors. The positional and / or other sensors provide sensitive positional and / or other information that may be used to sensitively monitor pelvic floor movements and / or to assess the pelvic floor architecture or other health aspect of a subject.

[0113] In particular, the intravaginal device can be used during a daily activity or during a diagnostic procedure to detect patterns of angle change. For example, specific sensors in the intravaginal device can be monitored during the diagnostic testing to assess patterns and angle changes in the pelvic floor as a proxy for assessing the physiology of the pelvic floor muscles. The patterns and angle changes can be compared to those observed before a diagnosis or treatment in the tested subject or in subjects having a known pelvic floor disorder (e.g., urinary incontinence or pelvic organ prolapse) in order to accurately diagnose the pelvic floor disorder in the tested subject. The device may also be used to treat a female subject with a pelvic floor disorder. When a female patient performs a pelvic floor exercise with the device, the position of the pelvic floor musculature can be monitored during the exercise to ensure that she is performing the exercise correctly and maintaining activation of the pelvic floor muscles for a sufficient duration of time (e.g., a hold or lift).

[0114] Trends and patterns of angle changes of the sensors (e.g., MEMS accelerometers) observed in the intravaginal device during monitoring may be used to diagnose or predict a disease state based on the positions, movements, and relative orientation of the pelvic floor muscles (e.g., the various levator ani and anal sphincter muscle groups) and / or the pelvic floor organs or to assess the efficacy of a chosen therapy in the subject.

[0115] Exemplary intravaginal devices, systems, and methods for treating, training, visualizing, and diagnosing the health state of pelvic floor muscles of a subject have been extensively described in PCT Publication Nos. WO / 2013 / 116310, WO / 2015 / 103629, WO / 2018 / 023037, WO / 2019 / 084469, WO / 2019 / 084468, WO / 2019 / 200222, WO / 2020 / 092343, and WO / 2021 / 236768, and in US design patents D898911 , D956,229, D958,987, D897530, D899593, D922.575, D888948, D888949, D889649, D896958, and D896,959, the disclosures of which are hereby incorporated by reference in their entirety. Exemplary devices include the LEVA® and LIFT® pelvic floor health devices. The LEVA® intravaginal device has an elongate body configured to fit within the vagina. The device contains a substantially cylindrical elongate body with six accelerometers mounted on a flexible printed circuit board within the device. The device is described and shown, e.g., in PCT Publication Nos. WO 2013 / 116310 and WO 2015 / 103629, and in US design patents D898911 , D956,229, D958,987, The LIFT® Device contains a ring attached to a linear tether. The LIFT® device and related devices containing a ring and tether embodiment are described, e.g., in PCT Publications Nos. WO / 2018 / 023037, WO / 2019 / 084469, WO / 2019 / 084468,

[0116] WO / 2019 / 200222, WO / 2020 / 092343, and WO / 2021 / 236768 and in US design patents D897530, D899593, D922.575, D888948, D888949, D889649, D896958, and D896,959.

[0117] The intravaginal device may include one or more (e.g., 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more) positional sensors that are configured to detect a muscle movement, e.g., a PFL and / or a PFR. In some instances, the sensors (e.g., 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, or more sensors) may be selected from the group consisting of a movement sensor, an orientation sensor, a gyroscope, a micro-electro-mechanical systems (MEMS) sensor (e.g., MEMS accelerometer), a G-sensor, a tilt sensor, a rotation sensor, a pressure sensor, a light detecting sensor, such as a LiDAR sensor, an EIM sensor, and combinations thereof.

[0118] The intravaginal device (may further includes a microcontroller for receiving data from the sensor(s). The microcontroller may also be configured, or can include a separate component, for non- transiently storing data from the sensor(s). The microcontroller may be connected to the sensor(s), e.g., by a wire and / or a circuit board. The wire and circuit board may be flexible or rigid (e.g., a flexible printed circuit board).

[0119] The intravaginal device can also include a transmitter and receiver within the device form for communicating wirelessly or via a detachable cable with a peripheral device (e.g., a handheld or portable device or a computer, such as a smartphone, tablet, or laptop), e.g., via a relay device. Alternatively, the transmitter and receiver may be located in an external housing and connected to the intravaginal device wirelessly or by a detachable cable. The transmitter and receiver can be connected directly or indirectly to the microcontroller, sensor(s), and / or circuit board. The transmitter and receiver may configured for use with a radio frequency (RF) transceiver. The transmitter and receiver may communicate with the transceiver e.g., using BLUETOOTH® low energy (BLE), industrial, scientific, and medical (ISM), medical implant communication service (MICS), Wi-Fi, or RF. Information collected by the sensor(s) may be communicated (e.g., downloaded, transferred) to the peripheral device wirelessly by the transmitter and receiver, e.g., via an RF transceiver relay device, and / or by using a detachable cable.

[0120] The intravaginal device may further include a power source (e.g., a battery). The power source can be used to operate one or more components of the device, such as the sensor(s), transmitter, receiver, and the circuit board.

[0121] Systems and Kits

[0122] The devices and components described herein may be present as part of a kit or system. For example, the systems and kits described herein may include one or more of an intravaginal device, a peripheral device, a radio frequency transceiver, one or more sensors, microcontrollers, transmitters, receivers, and the like. If packaged in a kit, the kit may further include instructions for use thereof. The system or kit may further include a cap or cover for the intravaginal device. The cap or cover may optionally include a radio frequency transceiver. The peripheral device (e.g., smartphone) may further include a mobile application or web-based application.

[0123] Database

[0124] A database may be located on a local electronic device (e.g., a peripheral device, such as a computer, phone, or tablet) or on a remote electronic device that can communicate via the internet (e.g., a web-located and / or cloud-based database). The database can be a central database that collects, stores, and performs calculations with the sensor data collected from an intravaginal device used by a subject. Sensor data and additional data provided by an individual (e.g., information provided by an individual on symptoms of a pelvic floor disorder that they have experienced, e.g., answers to a questionnaire) may be communicated to (e.g., uploaded to) or stored in the database on a periodic basis upon transmission from the intravaginal device. In some instances, communication with the database is substantially continuous (e.g., upload of data occurs in substantially real-time during the performance of a pelvic floor exercise). In other instances, communication with the database occurs on an hourly or daily basis (e.g., at least one per hour and / or at least once per day) or when initiated by the user. The database can be reviewed by the user after treatment to assess the progress. The data could also been transmitted to the healthcare provider (e.g., automatically, by a third party, or by the user).

[0125] Pelvic Floor Disorders

[0126] The devices, systems and methods of the invention may be used to monitor, diagnose, and treat a pelvic floor disorder. Pelvic floor disorders include urinary tract disorders, which are disorders that impart difficulties in bladder storage, and urinary incontinence, which includes an inability of the body to control the discharge of urine. Types and prevalence of incontinence among ambulatory adult women include stress urinary incontinence (SUI), detrusor instability (urge incontinence), mixed incontinence (stress and urge), and other incontinence (overflow, neurogenic). The prevalence of detrusor muscle instability and of mixed incontinence has been observed to increase with age of the subject sample. Male subjects may experience similar incontinence problems, which are often associated with an enlarged prostate gland. Males also have urine retention issues due to the prostate.

[0127] SUI may be characterized by involuntary loss of urine occurring when, in the absence of a detrusor contraction, intravesical pressure exceeds maximum urethral pressure. Stress urinary incontinence may include accidental loss of urine resulting from laughing, sneezing, coughing, or standing up, as any such exertion causes increased abdominal pressure, as transmitted to the bladder and the urine contained therein, to exceed the resistance to flow generated by the urethra, and principally the urethral sphincter. SI may be further categorized as hypermobility of the bladder neck and intrinsic sphincteric deficiency (ISD).

[0128] Hypermobility of the bladder neck may result from descent of the pelvic floor and may be attributed to weakened pelvic floor muscles and connective tissue. This may be observed in combination with nerve damage to the external genitalia resulting from childbirth but may also occur in younger women who have not given birth. In a normal position, the bladder is supported by the pelvic muscles, which prevent increases in abdominal pressure from exceeding urethral pressure. When the pelvic muscles are weakened or damaged, the bladder neck is abnormally displaced during abdominal stress and the urethral sphincter closure pressure becomes inadequate to maintain continence. Loss of urine due to hypermobility-related SI typically occurs in a periodic manner and the volume of urine may be proportional to the severity of the condition.

[0129] ISD is a severe form of stress incontinence which may occur due to an intrinsic deficiency of the urethral closure mechanism or due to a dysfunctional urethra where the bladder neck is open at rest. Severe ISD results in continuous leakage of urine or leakage responsive to only minimal subject exertion. In ISD, the bladder neck may be fixed, or hypermobile. ISD occurs in a significant number of instances due to urethral scarring from past incontinence surgeries but may result from other causes. Only a small number of subjects exhibit stress incontinence attributable to ISD.

[0130] EXAMPLES

[0131] The following examples are put forth so as to provide those of ordinary skill in the art with a description of how the compositions and methods claimed herein are performed, made, and evaluated, and are intended to be purely exemplary for use in the compositions and methods of the invention and are not intended to limit the scope of what the inventors regard as their invention.

[0132] Example 1. Predicting a likelihood of success for pelvic floor exercise therapy

[0133] Subjects with urinary incontinence performed a series of pelvic floor exercise sessions, and their treatment progress was tracked over the course of 12 weeks (84 days). The pelvic floor exercise sessions consisted of alternating pelvic floor lifts and pelvic floor relaxations performed for 15 seconds each. This was repeated 5 times for a total of 2.5 minutes. The 2.5-minute sessions were repeated twice daily over the course of treatment.

[0134] Data points were identified by using a cohort of sequential patients who used LEVA® (Axena Health, Inc., Boston, MA; levatherapy.com) for the treatment of urinary incontinence. Patients included in the analysis had a baseline Urinary Distress Inventory (UDI-6) score of >37.5 and had completed baseline and one additional UDI-6 survey. The UDI-6 survey is described, e.g., in Skorupska et al. (Health Qual Life Outcomes 19:87, 2021 ). The Patient Acceptable Symptom State (PASS) scale of female urinary incontinence was used as a subjective measure of patient treatment (see, e.g., Sanderson et al. Female Pelvic Medicine and Reconstrunctive Surgery 28:1 , 33-39, 2021 ). The PASS was assessed using the question “Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?” Patients were considered to have achieved PASS if they responded “yes” to this question.

[0135] All data points were provided through the LEVA® application by direct entry (demographics, UDI- 6 surveys) or passive data collection with intravaginal device use. Variables collected included adherence to the treatment regimen, average angle change with lift, and average hold time of lift.

[0136] The graph shown in FIG. 1 was created by plotting the daily angle values for each user averaged over the days of use. The graph demonstrates usage over 12 weeks (84 days). A binary outcome of the PASS (PASS+ or PASS-, corresponding to met or not met) for the UDI-6 (i.e., a score of > or <37.5) was employed using the baseline and last-reported UDI-6 score. Participants not providing a second score or who had a baseline score <37.5 were not included in the analysis. Using a mixed methods model, the difference between the two graphs was shown to be statistically significant. The two trend lines corresponding to average lift angle for PASS(+) or PASS(-) were fit with a linear regression and had the following equations: PASS (+) y=7.22 + 2.85 * log(x) PASS (-) y=7.82 + 1 .97 * log(x)

[0137] The PASS(+) trend line had a higher y-intercept and a higher slope than the PASS(-) trend line, indicative of more meaningful change in average pelvic floor lift angle over the course of treatment. Thus, a data point for a subject falling above the PASS(-) curve could be expected to produce a likelihood of success for pelvic floor treatment therapy. In contrast, a data point following below the PASS(-) trend line could be expected to produce an unlikelihood of success for pelvic floor treatment therapy.

[0138] A predictive model was created that utilized a linear regression to model the slope of the line for the angle change resulting from pelvic floor lift using LEVA®. This information was used along with demographic, utilization, and urinary incontinence severity information that were fit into an “all in” logistic regression model. This model was able to predict with 70% accuracy the likelihood of success or failure as measured by meeting the PASS standard.

[0139] Example 2. Optimizing the Treatment Algorithm

[0140] As shown in FIG. 2, an algorithm can be optimized over time as more data is input into a model. Multiple factors are weighted based on their degree of association with the outcome (+ / - PASS). This is based on the type of regression analysis used (e.g., logistic regression, random forest, k-means) which is then used in a supervised machine learning protocol. The algorithm described herein included a regression that involved both linear and logistic regression. Once an initial analysis of historic data is performed, the model is trained (enhanced / honed) and tested using additional existing data. This tests the model’s predictive ability on new data that was not used to create the initial model. Once the model has been optimized for sensitivity and or specificity, it can then be used to predict outcomes for new patients on an individual level. The selection of the degree of sensitivity and specificity (false negatives or positives) is determined based on the use of the model. For example, if one were to use the model to influence coaching, one would be interested in minimizing the number of false positives. If one were to use the model as a precursor to surgery, eliminating false negatives would be the focus.

[0141] The weighting may be determined by the analysis of a historical data set, trained and validated on a new data set, and then applied to individuals. Weighting may be determined by a regression analysis that arrives at the best “fit” for all the variables, to provide a regression model that is most predictive. Exemplary weighting curves and variables are shown in FIG. 3 and Tables 1 and 2. FIG. 4 shows how the likelihood of success can increase based on increased compliance.

[0142] Table 1 : Weighting Coefficients

[0143] Table 2: Empirical Standard Error Estimates Full Model 2

[0144] Example 3. Continuing pelvic floor exercise therapy

[0145] A subject with urinary incontinence performs a series of pelvic floor exercise sessions, and their treatment progress is tracked over the course of 12 weeks. The pelvic floor exercise sessions consist of alternating pelvic floor lifts and pelvic floor relaxations performed for 15 seconds each. This is repeated 5 times for a total of 2.5 minutes. The 2.5-minute sessions are repeated twice daily over the course of treatment. The subject performs the exercises with an intravaginal device that tracks her performance and a smartphone application that displays the progress of her performance.

[0146] The subject has a baseline UDI-6 score of 40 and completes baseline and one additional UDI-6 survey following two weeks of therapy. The subject’s symptoms, including whether the subject has reached a minimal clinically important difference and / or reached the PASS is assessed after two weeks, and the subject indicates that they are not fully treated and are still experiencing regular episodes of incontinence.

[0147] A performance metric is established for the subject following two weeks of exercise. The performance metric indicates that the user is improving in her lift exercises after 2 weeks consistent with the trend line of the predetermined threshold of previous subjects who have been treated according to the same exercise regimen.

[0148] After 12 weeks of the therapy, a second performance metric is established, and the user is still showing improvement in her performance of pelvic floor exercises as evidenced by an increase in average pelvic floor lift angle. The subject also responds to the symptom survey questions showing that she is being effectively treated, and her episodes of incontinence have not appeared during the past two weeks. The second performance metric indicates that the subject is nearing an end to her treatment and that she should continue for another four weeks to further strengthen the pelvic floor.

[0149] The subject has a UDI-6 score of 20 following 12 weeks of therapy and discontinues her pelvic floor exercise treatment.

[0150] Example 4. Discontinuing pelvic floor exercise therapy.

[0151] A subject with urinary incontinence performs a series of pelvic floor exercise sessions, and their treatment progress is tracked over the course of 6 weeks. The pelvic floor exercise sessions consist of alternating pelvic floor lifts and pelvic floor relaxations performed for 15 seconds each. This is repeated 5 times for a total of 2.5 minutes. The 2.5-minute sessions are repeated twice daily over the course of treatment. The subject performs the exercises with an intravaginal device that tracks her performance and a smartphone application that displays the progress of her performance.

[0152] The subject has a baseline UDI-6 score of 50 and completes baseline and one additional UDI-6 survey following two weeks of therapy. The subject’s symptoms, including whether the subject has reached a minimal clinically important difference and / or reached the PASS is assessed after two weeks, and the subject indicates that they are not fully treated and are still experiencing regular episodes of incontinence. Her disease state is still severe.

[0153] A performance metric is established for the subject following two weeks of exercise. The performance metric indicates that the user is not improving in her lift exercises after 2 weeks consistent with the trend line of the predetermined threshold of previous subjects who have been treated according to the same exercise regimen. She is unlikely to be responsive to treatment using this current exercise protocol.

[0154] The subject alters her pelvic floor exercise regimen to include 4 daily sessions of 2.5-minute exercises. Four weeks later, a second performance metric is established, and the user is still not showing sufficient improvement in her performance of pelvic floor exercises as evidenced by a plateau in average pelvic floor lift angle. The subject also responds to the symptom survey questions showing that she is not being effectively treated, and her episodes of incontinence remain constant appeared during the past six weeks. The second performance metric indicates that the subject is not responsive to treatment and is unlikely to be treated with pelvic floor exercise therapy.

[0155] The subject has a UDI-6 score of 40 following 6 weeks of therapy and discontinues her pelvic floor exercise treatment. A health care provider suggests she try an alternative therapy, such as electrical stimulation therapy, to see if symptoms resolve.

[0156] OTHER EMBODIMENTS

[0157] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each independent publication or patent application was specifically and individually indicated to be incorporated by reference.

[0158] While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations for use in the compositions and methods of the invention following, in general, the principles for use in the compositions and methods of the invention and including such departures from the present disclosure that come within known or customary practice within the art to which the invention pertains and may be applied to the essential features hereinbefore set forth, and follows in the scope of the claims. Other embodiments are within the claims.

Claims

CLAIMS1 . A method of treating a pelvic floor disorder in a subject comprising:(a) obtaining positional data from one or more sensors of an intravaginal device during performance of a pelvic floor exercise during a first treatment phase of a first therapy;(b) processing the positional data from the one or more sensors to establish a performance metric; and(c) continuing treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, wherein the performance metric is above a predetermined threshold; or performing a second therapy that is different from the first therapy in the subject, wherein the performance metric is below the predetermined threshold.

2. The method of claim 1 , further comprising obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase.

3. The method of claim 2, wherein step (c) comprises processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

4. A method of determining a predetermined threshold of a performance metric from positional data of pelvic floor exercise therapy:(a) obtaining positional data from one or more sensors of an intravaginal device during performance of a pelvic floor exercise during a first treatment phase of a first therapy;(b) obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase; and(c) processing the positional data from the one or more sensors and the survey questionnaire data to establish a predetermined threshold of the performance metric.

5. The method of any one of claims 2-4, wherein the survey questionnaire comprises a Urinary Distress Inventory (UDI-6) survey and / or other assessment of whether the subject has reached a Patient Acceptable Symptom State (PASS).

6. The method of claim 5, wherein the survey questionnaire data is obtained prior to the first treatment phase of the first therapy and following at least a portion of the first treatment phase.

7. The method of any one of claims 1 -6, wherein processing the data comprises processing data regarding subject adherence to the first treatment phase of the first therapy.

8. The method of any one of claims 1 -7, wherein the performance metric varies with respect to time.

9. The method of claim 8, wherein the performance metric increases linearly with respect to time.

10. The method of claim 8 or 9, wherein processing the data comprises performing a linear regression of the positional data.11 . The method of any one of claims 1 -10, wherein the predetermined threshold varies as a function of age of the subject, type of pelvic floor disorder diagnosed, and / or severity of the pelvic floor disorder.

12. The method of any one of claims 1 -11 , wherein the positional data includes sensor angle and / or time.

13. The method of any one of claims 1 -12, wherein the performance metric comprises average lift angle, average lift duration, frequency of lift, or a combination thereof.

14. The method of any one of claims 1 -13, wherein the first treatment phase is from 1 day to 16 weeks.

15. The method of claim 14, wherein the first treatment phase is from 1 to 12 weeks.

16. The method of any one of claims 1 -15, wherein the second treatment phase is from 1 day to 1 year.

17. The method of claim 16, wherein the second treatment phase is from 1 week to 16 weeks.

18. The method of any one of claims 1 -17, wherein the second treatment phase is continued until one or more symptoms of the pelvic floor disorder are reduced or resolved.

19. The method of any one of claims 1 -18, wherein processing the positional data comprises using an algorithm to calculate the performance metric based on a change in sensor angle over time.

20. The method of any one of claims 1 -19, wherein processing the positional data comprises using a factor that weights the score based on age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, type of pelvic floor disorder diagnosed, severity of disease, and / or treatment regimen adherence.21 . The method of any one of claims 1 -20, wherein the intravaginal device comprises a plurality of sensors located along a length of the device.

22. The method of any one of claims 1 -21 , wherein the sensors are microelectromechanical (MEM) accelerometers.

23. The method of any one of claims 1 -22, wherein the predetermined threshold is calculated based on performance of the first therapy by a population of at least 50 subjects.

24. The method of claim 23, wherein a first subset of the population of subjects has been determined to be responsive to the first therapy and a second subset of the population of subjects has been determined to be nonresponsive to the first therapy.

25. The method of claim 23 or 24, wherein the predetermined threshold of the performance metric comprises a minimum clinical important difference (MCID) or a patient acceptable symptom state (PASS) of the population.

26. The method of any one of claims 1 -25, wherein the first treatment phase comprises performing alternating pelvic floor lifts and pelvic floor relaxations.

27. The method of claim 26, wherein the first treatment phase comprises performing 15 seconds of pelvic floor lifts and 15 seconds of pelvic floor relaxations.

28. The method of claim 26 or 27, wherein the pelvic floor lifts and pelvic floor relaxations are repeated one or more times.

29. The method of claim 28, wherein the pelvic floor lifts and pelvic floor relaxations are repeated five times for a duration of 2.5 minutes.

30. The method of any one of claims 26-29, wherein the pelvic floor lifts and pelvic floor relaxations are repeated twice daily.31 . The method of any one of claims 1 -30, wherein the second treatment phase of the first therapy is the same as the first treatment phase of the first therapy.

32. The method of any one of claims 1 -30, wherein the second treatment phase comprises performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first treatment phase of the first therapy.

33. The method of any one of claims 1 -32, wherein the second therapy comprises performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first therapy.

34. The method of any one of claims 1 -33, wherein the second therapy comprises electrical stimulation therapy, anticholinergic or beta-agonist therapy, use of an incontinence pessary, peripheral neuromodulation, tibial neuromodulation, sacral neuromodulation, periurethral bulking, an intravaginal balloon or other prosthetic, or surgical intervention.

35. The method of claim 34, wherein the surgical intervention comprises a mid-urethral sling, a rectus fascia sling, a Burch colposuspension procedure, or a Marshall Marchetti Krantz (MMK) culposuspension procedure.

36. The method of any one of claims 1 -35, further comprising:(i) obtaining positional data from one or more sensors of an intravaginal device used during performance of the one or more pelvic floor lifts during the second therapy; and(ii) processing the positional data from the one or more sensors to establish a second performance metric to determine the likelihood of treatment success of the second therapy.

37. The method of claim 36, wherein the second performance metric is above a predetermined threshold, and the method comprises continuing treatment of the pelvic floor disorder during a second treatment phase of the second therapy, or wherein the second performance metric is below the predetermined threshold, and the method comprises performing a third therapy that is different from the second therapy.

38. The method of any one of claims 1 -37, further comprising discontinuing treatment when one or more symptoms of the pelvic floor disorder are reduced or resolved.

39. The method of any one of claims 1 -38, wherein the performance metric is displayed on a peripheral device comprising a computer processing unit configured to receive and process data from the one or more sensors of the intravaginal device.

40. The method of claim 39, wherein the peripheral device displays progress of the performance metric over time.41 . The method of any one of claims 1 -40, wherein the peripheral device comprises an audio and / or visual alert that provides feedback to the subject.

42. The method of any one of claims 1 -41 , wherein the peripheral device comprises settings for personalizing operation of the intravaginal device for the subject relative to the performance metric.

43. The method of any one of claims 1 -42, wherein the subject has a UDI-6 score of greater than or equal to 37.5 prior to treatment.

44. The method of any one of claims 1 -43, wherein the subject has a UDI-6 score of less than or equal to 37.5 after treatment.

45. A peripheral device comprising a computer processing unit configured to receive data from one or more sensors of an intravaginal device, wherein the peripheral device is configured to:(a) obtain positional data from the one or more sensors of the intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and(b) process the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy; and(c) direct the user to continue treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, wherein the performance metric is above a predetermined threshold; or direct the user to perform a second therapy that is different from the first therapy in the subject wherein the performance metric is below the predetermined threshold.

46. The peripheral device of claim 45, wherein the peripheral device is further configured to obtain survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase.

47. The peripheral device of claim 46, wherein the peripheral device is further configured to process the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

48. The peripheral device of any one of claims 45-47, wherein the peripheral device is a smartphone or tablet.

49. The peripheral device of any one of claims 45-58, wherein the peripheral device comprises a graphical user interface.

50. The peripheral device of claim 49, wherein the graphical user interface is a touchscreen graphical user interface.51 . The peripheral device of any one of claims 45-50, wherein the peripheral device is configured to perform the method of any one of claims 1 -30.

52. A system comprising the peripheral device of any one of claims 45-51 and the intravaginal device comprising one or more sensors.

53. The system of claim 52, wherein the intravaginal device has a plurality of sensors located along a length of the device.

54. The system of claim 52 or 53, wherein the sensors are MEM accelerometers.

55. The system of any one of claims 52-54, wherein the peripheral device comprises settings for personalizing operation of the intravaginal device for the subject relative to the performance metric.

56. A method of treating a pelvic floor disorder in a subject comprising:(a) obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and(b) processing the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy.

57. The method of claim 56, further comprising obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase.

58. The method of claim 57, wherein step (b) comprises processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

59. The method of any one of claims 56-58, wherein the likelihood of treatment success is positive if the performance metric is above a predetermined threshold, or wherein the likelihood of treatment success is negative if the performance metric is below the predetermined threshold.

60. The method of any one of claims 56-59, wherein the performance metric is above the predetermined threshold, and the method further comprises continuing treatment during a second treatment phase of the first therapy.61 . The method of any one of claims 56-59, wherein the performance metric is below the predetermined threshold, and the method further comprises performing a second therapy that is different from the first therapy.

62. A method of treating a pelvic floor disorder in a subject comprising:(a) obtaining positional data from one or more sensors of an intravaginal device during performance of a pelvic floor exercise during a first treatment phase of a first therapy;(b) processing the positional data from the one or more sensors to establish a performance metric; and(c) continuing treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, wherein the performance metric is above a predetermined threshold; or performing a second therapy that is different from the first therapy in the subject, wherein the performance metric is below the predetermined threshold.

63. The method of claim 62, further comprising obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase.

64. The method of claim 63, wherein step (c) comprises processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

65. A method of determining a predetermined threshold of a performance metric from positional data of pelvic floor exercise therapy:(a) obtaining positional data from one or more sensors of an intravaginal device during performance of a pelvic floor exercise during a first treatment phase of a first therapy;(b) obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase; and(c) processing the positional data from the one or more sensors and the survey questionnaire data to establish a predetermined threshold of the performance metric.

66. The method of claim 63, wherein the survey questionnaire comprises a Urinary Distress Inventory (UDI-6) survey and / or other assessment of whether the subject has reached a Patient Acceptable Symptom State (PASS).

67. The method of claim 66, wherein the survey questionnaire data is obtained prior to the first treatment phase of the first therapy and following at least a portion of the first treatment phase.

68. The method of claim 62, wherein processing the data comprises processing data regarding subject adherence to the first treatment phase of the first therapy.

69. The method of claim 62, wherein the performance metric varies with respect to time.

70. The method of claim 69, wherein the performance metric increases linearly with respect to time.71 . The method of claim 69, wherein processing the data comprises performing a linear regression of the positional data.

72. The method of claim 62, wherein the predetermined threshold varies as a function of age of the subject, type of pelvic floor disorder diagnosed, and / or severity of the pelvic floor disorder.

73. The method of claim 62, wherein the positional data includes sensor angle and / or time.

74. The method of claim 62, wherein the performance metric comprises average lift angle, average lift duration, frequency of lift, or a combination thereof.

75. The method of claim 62, wherein the first treatment phase is from 1 day to 16 weeks.

76. The method of claim 75, wherein the first treatment phase is from 1 to 12 weeks.

77. The method of claim 62, wherein the second treatment phase is from 1 day to 1 year.

78. The method of claim 77, wherein the second treatment phase is from 1 week to 16 weeks.

79. The method of claim 62, wherein the second treatment phase is continued until one or more symptoms of the pelvic floor disorder are reduced or resolved.

80. The method of claim 62, wherein processing the positional data comprises using an algorithm to calculate the performance metric based on a change in sensor angle over time.81 . The method of claim 62, wherein processing the positional data comprises using a factor that weights the score based on age, weight, medical history, race, level of exercise, reproductive history, income level, occupation, type of pelvic floor disorder diagnosed, severity of disease, and / or treatment regimen adherence.

82. The method of claim 62, wherein the intravaginal device comprises a plurality of sensors located along a length of the device.

83. The method of claim 62, wherein the sensors are microelectromechanical (MEM) accelerometers.

84. The method of claim 62, wherein the predetermined threshold is calculated based on performance of the first therapy by a population of at least 50 subjects.

85. The method of claim 84, wherein a first subset of the population of subjects has been determined to be responsive to the first therapy and a second subset of the population of subjects has been determined to be nonresponsive to the first therapy.

86. The method of claim 84, wherein the predetermined threshold of the performance metric comprises a minimum clinical important difference (MCID) or a patient acceptable symptom state (PASS) of the population.

87. The method of claim 62, wherein the first treatment phase comprises performing alternating pelvic floor lifts and pelvic floor relaxations.

88. The method of claim 87, wherein the first treatment phase comprises performing 15 seconds of pelvic floor lifts and 15 seconds of pelvic floor relaxations.

89. The method of claim 87, wherein the pelvic floor lifts and pelvic floor relaxations are repeated one or more times.

90. The method of claim 89, wherein the pelvic floor lifts and pelvic floor relaxations are repeated five times for a duration of 2.5 minutes.91 . The method of claim 87, wherein the pelvic floor lifts and pelvic floor relaxations are repeated twice daily.

92. The method of claim 62, wherein the second treatment phase of the first therapy is the same as the first treatment phase of the first therapy.

93. The method of claim 62, wherein the second treatment phase comprises performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first treatment phase of the first therapy.

94. The method of claim 62, wherein the second therapy comprises performing one or more pelvic floor lifts with an increased frequency, duration, and / or intensity of pelvic floor lifts relative to the first therapy.

95. The method of claim 62, wherein the second therapy comprises electrical stimulation therapy, anticholinergic or beta-agonist therapy, use of an incontinence pessary, peripheral neuromodulation, tibial neuromodulation, sacral neuromodulation, periurethral bulking, an intravaginal balloon or other prosthetic, or surgical intervention.

96. The method of claim 95, wherein the surgical intervention comprises a mid-urethral sling, a rectus fascia sling, a Burch colposuspension procedure, or a Marshall Marchetti Krantz (MMK) culposuspension procedure.

97. The method of claim 62, further comprising:(i) obtaining positional data from one or more sensors of an intravaginal device used during performance of the one or more pelvic floor lifts during the second therapy; and(ii) processing the positional data from the one or more sensors to establish a second performance metric to determine the likelihood of treatment success of the second therapy.

98. The method of claim 97, wherein the second performance metric is above a predetermined threshold, and the method comprises continuing treatment of the pelvic floor disorder during a second treatment phase of the second therapy, or wherein the second performance metric is below the predetermined threshold, and the method comprises performing a third therapy that is different from the second therapy.

99. The method of claim 62, further comprising discontinuing treatment when one or more symptoms of the pelvic floor disorder are reduced or resolved.

100. The method of claim 62, wherein the performance metric is displayed on a peripheral device comprising a computer processing unit configured to receive and process data from the one or more sensors of the intravaginal device.101 . The method of claim 100, wherein the peripheral device displays progress of the performance metric over time.

102. The method of claim 62, wherein the peripheral device comprises an audio and / or visual alert that provides feedback to the subject.

103. The method of claim 62, wherein the peripheral device comprises settings for personalizing operation of the intravaginal device for the subject relative to the performance metric.

104. The method of claim 62, wherein the subject has a UDI-6 score of greater than or equal to 37.5 prior to treatment.

105. The method of claim 62, wherein the subject has a UDI-6 score of less than or equal to 37.5 after treatment.

106. A peripheral device comprising a computer processing unit configured to receive data from one or more sensors of an intravaginal device, wherein the peripheral device is configured to:(a) obtain positional data from the one or more sensors of the intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and(b) process the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy; and(c) direct the user to continue treatment of the pelvic floor disorder during a second treatment phase of the first therapy in the subject, wherein the performance metric is above a predetermined threshold; or direct the user to perform a second therapy that is different from the first therapy in the subject wherein the performance metric is below the predetermined threshold.

107. The peripheral device of claim 106, wherein the peripheral device is further configured to obtain survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase.

108. The peripheral device of claim 107, wherein the peripheral device is further configured to process the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

109. The peripheral device of claim 106, wherein the peripheral device is a smartphone or tablet.

110. The peripheral device of claim 106, wherein the peripheral device comprises a graphical user interface.

111. The peripheral device of claim 110, wherein the graphical user interface is a touchscreen graphical user interface.

112. The peripheral device of claim 106, wherein the peripheral device is configured to perform the method of claim 62.

113. A system comprising the peripheral device of claim 106and the intravaginal device comprising one or more sensors.

114. The system of claim 113, wherein the intravaginal device has a plurality of sensors located along a length of the device.

115. The system of claim 113, wherein the sensors are MEM accelerometers.

116. The system of claim 113, wherein the peripheral device comprises settings for personalizing operation of the intravaginal device for the subject relative to the performance metric.

117. A method of treating a pelvic floor disorder in a subject comprising:(a) obtaining positional data from one or more sensors of an intravaginal device used during performance of one or more pelvic floor lifts during a first treatment phase of a first therapy; and(b) processing the positional data from the one or more sensors to establish a performance metric to determine a likelihood of treatment success of the first therapy.

118. The method of claim 117, further comprising obtaining survey questionnaire data from the subject comprising symptom severity, symptom improvement and / or user satisfaction following at least a portion of the first treatment phase.

119. The method of claim 118, wherein step (b) comprises processing the positional data from the one or more sensors and the survey questionnaire data to establish the performance metric.

120. The method of claim 117, wherein the likelihood of treatment success is positive if the performance metric is above a predetermined threshold, or wherein the likelihood of treatment success is negative if the performance metric is below the predetermined threshold.121 . The method of claim 117, wherein the performance metric is above the predetermined threshold, and the method further comprises continuing treatment during a second treatment phase of the first therapy.

122. The method of claim 117, wherein the performance metric is below the predetermined threshold, and the method further comprises performing a second therapy that is different from the first therapy.

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