Devices, systems, and methods for treating pelvic floor dysfunction

Abstract

Features are methods, peripheral devices, and systems including the same for determining a likelihood of success of a pelvic floor muscle treatment therapy. The methods can include conducting a treatment regimen, the treatment regimen including pelvic floor muscle exercises, and monitoring treatment efficacy to determine a likelihood of treatment success in order to continue treatment or employ an alternative therapy.

Description

Background Technology

[0001] Pelvic floor dysfunction (PFD) is a group of conditions that primarily affect women and are associated with weakened (e.g., decreased tone) or tight (e.g., excessive tone) pelvic floor muscles (PF). Many common factors can contribute to weakened or tight pelvic floor muscles in women, such as pregnancy, vaginal delivery, pelvic surgery, aging, genetic predisposition, neurological disorders, and weight gain. In the United States, 24% of women have PFD, of whom 16% experience urinary incontinence (UI), 3% experience pelvic organ prolapse (POP), and 9% experience anal or fecal incontinence (FI). The prevalence of PFD increases with age, reaching 10% in women aged 20-39 and 50% in women aged 80 or older. It is estimated that the number of women in the United States with at least one PFD will increase from 28.1 million in 2010 to 43.8 million in 2050 (Memon et al.). Women's Health (Lond. Engl.) (9(3), 2013). Although pelvic floor muscle exercises have become a common technique for treating PFD, they have not yielded significant therapeutic results in many subjects. Therefore, there is a need for improved methods and devices for the diagnosis, monitoring, and treatment of PFD to optimize pelvic floor muscle exercise therapy and tailor treatment protocols to maximize response. Summary of the Invention

[0002] On one hand, a method for treating pelvic floor muscle dysfunction in a subject is described. The method includes: (a) obtaining positional data from one or more sensors of an intravaginal device used during one or more pelvic floor muscle lifting exercises 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 for the pelvic floor muscle dysfunction during a second treatment phase of the first therapy in the subject, e.g., where the performance metric is above a predetermined threshold; or administering a second therapy to the subject different from the first therapy, e.g., where the performance metric is below the predetermined threshold. The method may further include obtaining questionnaire data from the subject, including symptom severity, symptom improvement, and / or user satisfaction, after at least a portion of the first treatment phase (e.g., after at least one day of pelvic floor muscle exercise treatment). Processing steps may include processing the positional data from the one or more sensors and the questionnaire data to establish a performance metric.

[0003] On the other hand, a method for treating pelvic floor dysfunction in a subject who is unresponsive to a first therapy (e.g., a first therapy including pelvic floor muscle exercises) using the intravaginal device is described. The method includes treating the subject with a second therapy different from the first therapy, for example, wherein the subject's unresponsiveness to the first therapy has been previously determined by: (a) obtaining positional data from one or more sensors of the intravaginal device used during one or more pelvic floor muscle elevations during a first treatment phase of the first therapy. The subject's unresponsiveness has been previously determined by: (b) processing the positional data from the one or more sensors to establish a performance metric thereby determining the likelihood of success of the first therapy; and (c) determining that the performance metric is below a predetermined threshold.

[0004] On the other hand, a feature is a method for determining a predetermined threshold for a performance metric based on location data from a pelvic floor muscle exercise therapy. The method includes (a) acquiring location data from one or more sensors installed intravaginally during pelvic floor muscle exercises at the start of a first treatment phase of the first therapy. The method further includes (b) obtaining questionnaire data from the subject, including symptom severity, symptom improvement, and / or user satisfaction, after at least a portion of the first treatment phase (e.g., after at least one day of pelvic floor muscle exercise therapy). The method may also include (c) processing the location data from the one or more sensors and the questionnaire data to establish the predetermined threshold for the performance metric.

[0005] The location data may include sensor angle and / or time. The performance metrics may include, for example, average lifting angle, average lifting duration, lifting frequency, number of days or weeks since the subject began treatment, number of treatment sessions since the subject began treatment, or combinations thereof (e.g., a composite score including one or more of average lifting angle, average lifting duration, and lifting frequency).

[0006] The performance metric may be a composite score that includes the average elevation angle and the Patient Acceptable Symptom Status (PASS) score, and may be weighted by other variables such as age, weight, medical history, race, exercise level, reproductive history, income level, occupation, type of pelvic floor dysfunction diagnosed, disease severity, and adherence to pelvic floor exercise programs. The composite score may include the average elevation angle, average elevation duration, and PASS score. The performance metric may also include scores or weighting coefficients that include one or more of the following from the subject: demographic, physiological, or medical history data, including, for example, weight, medical history, race, exercise level, reproductive history, income level, occupation, etc. Such data may be provided directly by the subject, caregiver, or medical record.

[0007] The first treatment phase can 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 1 week to 2 weeks (e.g., 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, or 14 days).

[0008] The method described herein includes collecting performance data during this first treatment phase, and this data may be processed to compare with historical data (e.g., from a group of subjects who have previously undergone the treatment) to determine the likelihood of success and / or whether alternative treatment options should be considered.

[0009] The second treatment phase can range from 1 day 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 can also range 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 can continue until one or more symptoms of the pelvic floor muscle dysfunction are reduced or eliminated.

[0010] Processing the data may include using algorithms. The processing may include using algorithms to calculate the performance metric based on changes in sensor angle over time (e.g., average lifting angle) or the duration of lifting performed by the subject. The processing may also include using algorithms to calculate the performance metric based on a composite score weighted by other variables (age, weight, medical history, race, exercise level, reproductive history, income level, occupation, type of diagnosed pelvic floor dysfunction, disease severity, and treatment adherence).

[0011] Data processing may include processing data from questionnaires that include ratings or questions related to symptom severity, symptom improvement, and / or user satisfaction. Questionnaires may include, for example, a Urinary Disturbance Scale-6 (UDI-6) survey and / or other assessments of whether the subject has achieved a Patient Acceptable Symptom State (PASS). Questionnaire data may be obtained before the start of the first phase of the first therapy and after at least a portion of the first phase (e.g., after at least one day of pelvic floor muscle training). Collecting more than one data point allows for tracking changes in the progress of survey questions (e.g., “Considering the various effects of urinary incontinence on you, are you satisfied with your current state?”).

[0012] Data processing may include processing data on subject adherence to the first phase of treatment. For example, if a subject is not adherent, the data or performance metric may be weighted by coefficients corresponding to how strictly the subject adhered to the treatment regimen (e.g., 0 for non-compliance and 1 for compliance).

[0013] Data processing may also include analyses of one or more of the following from the subjects: demographic, physiological, or medical history data, such as weight, medical history, race, exercise level, reproductive history, income level, occupation, etc. This type of data can be provided directly by the subjects, caregivers, or medical records.

[0014] In some implementations, performance metrics may vary with time (e.g., the metric may increase linearly with time, for example, as subject performance improves). The processing may include linear regression analysis on location data (e.g., for determining a ramp) or the duration of the lift performed by the subject (e.g., for determining time associated with a certain lift angle or ramp).

[0015] The predetermined thresholds and / or performance metrics may vary with the subject's age, the type of pelvic floor muscle dysfunction diagnosed, and / or the severity of the pelvic floor muscle dysfunction. The intravaginal device may include multiple sensors positioned along the length of the device. The sensors may be microelectromechanical systems (MEMS) accelerometers.

[0016] In some implementations, the predetermined threshold is calculated based on a population of subjects receiving the first treatment. The subject population may include at least 50 subjects (e.g., at least 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, or more subjects). For example, the subject population may include a first subset of the subject population that has been identified as responding to the first treatment and a second subset of the subject population that has not responded to the first treatment. The predetermined threshold for the performance metric may include the minimum clinically important difference (MCID) or patient-acceptable symptom status (PASS) of the population.

[0017] Performance metrics (e.g., the subject's average lift angle or lift duration) can vary with time. For example, performance metrics (e.g., the subject's average lift angle or lift duration) can increase linearly with time, for example, as the subject improves their performance.

[0018] Performance metrics can be an average lift angle of 5° to 40°, for example, 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°). Performance metrics can be an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first week of the first therapy. Performance metrics can be an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first two weeks of the first therapy. Performance metrics may be, after the first treatment phase of the first therapy at three weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at four weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at five weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at six weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at seven weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at eight weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be performed weekly, or as needed, in relation to the subject's therapy.

[0019] Performance measures can be the duration a subject can maintain an upward lift at a certain upward 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°). Performance measures can also be the duration of a subject maintaining an upward lift at an average upward angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first week of the first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a two-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a three-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a four-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a five-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a six-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a seven-week first therapy. Performance metrics can be the duration of elevation at an average angle of 5° to 40° (e.g., 5° to 30°) following the first treatment phase of the first eight-week therapy. Performance metrics can be performed weekly or, as needed, in relation to the subject's therapy.

[0020] The first treatment phase may include a defined set of pelvic floor muscle exercises. For example, the first treatment phase may include alternating pelvic floor muscle lifts and pelvic floor muscle relaxations. For example, the first treatment phase may include performing a 15-second pelvic floor muscle lift and a 15-second pelvic floor muscle relaxation. The pelvic floor muscle lifts and pelvic floor muscle relaxations may be repeated once or multiple times (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more times). For example, pelvic floor muscle lifts and pelvic floor muscle relaxations may be repeated five times for a duration of 2.5 minutes. These sessions may be repeated twice daily; for example, a 2.5-minute session including pelvic floor muscle lifts and pelvic floor muscle 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 from the first treatment phase of the first therapy. In some embodiments, the second treatment phase includes one or more pelvic floor muscle lifts with increased frequency, duration, and / or intensity relative to the first treatment phase of the first therapy.

[0022] The second therapy method may differ from the first therapy method. The second therapy may include performing one or more pelvic floor muscle lifts with increased frequency, duration, and / or intensity relative to the first therapy. The second therapy may include alternative treatments, such as… Electrical stimulation therapy, anticholinergic or beta-agonist therapy, use of a pessary for urinary incontinence, peripheral nerve modulation, tibial nerve modulation, sacral nerve modulation, perineal padding, intravaginal balloon or other prosthetic or surgical interventions (e.g., mid-urethral suspension, rectus abdominis fascia suspension, Burch colposuspension procedure or Marshall Marchetti Krantz (MMK) culposuspension procedure).

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

[0024] In some embodiments, the second performance metric is above a predetermined threshold, and the method includes continuing treatment for the pelvic floor muscle dysfunction 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 different from the second therapy.

[0025] The methods described herein may include, for example, interrupting treatment when one or more symptoms of the pelvic floor muscle dysfunction are relieved or resolved, such as after the first or second phase of the first therapy or after the second therapy.

[0026] The methods described herein may include questionnaires, such as the UDI-6 survey. Subjects' UDI-6 scores before treatment may be greater than or equal to 37.5. Subjects' UDI-6 scores after treatment may be less than or equal to 37.5.

[0027] In some implementations, the method is performed using a peripheral device. For example, the performance metric may be displayed on the peripheral device, which 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, for example, the progress of the performance metric over time. The peripheral device may include audio and / or visual alerts to provide feedback to the subject. The peripheral device may include settings for, for example, personalizing the operation of the intravaginal device on the subject with respect to the performance metric.

[0028] On the other hand, a feature is a peripheral device comprising 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 one or more pelvic floor muscle elevations during a first treatment phase of the first therapy; and (b) process the positional data from the one or more sensors to establish a performance metric to determine the likelihood of success of the first therapy. The peripheral device may be further configured to: (c) instruct a user to continue treatment for the pelvic floor muscle dysfunction during a second treatment phase of the first therapy for the subject, wherein the performance metric is above a predetermined threshold; or instruct the user to administer a second therapy to the subject different from the first therapy, wherein the performance metric is below the predetermined threshold.

[0029] The peripheral device may be further configured to obtain questionnaire data from the subject, including symptom severity, symptom improvement, and / or user satisfaction, after at least a portion of the first treatment phase, for example, by inputting it into a graphical user interface. The peripheral device may be further configured to process the location data from the one or more sensors and the questionnaire data to establish performance metrics.

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

[0031] On the other hand, a feature is a system comprising a peripheral device as described herein (e.g., the peripheral device in any of the above embodiments) and an intravaginal device including one or more sensors (e.g., a MEM accelerometer). The intravaginal device may include multiple sensors positioned along the length of the device. The peripheral device may include settings for, for example, personalizing the operation of the intravaginal device on the subject with respect to the performance metric.

[0032] On the other hand, a feature is a method for treating pelvic floor muscle dysfunction by determining the likelihood of treatment success. The method includes: (a) obtaining location data from one or more sensors of the intravaginal device used during one or more pelvic floor muscle lifting sessions during a first treatment phase of a first therapy; and (b) processing the location data from the one or more sensors to establish a performance metric, thereby determining the likelihood of treatment success of the first therapy. The method may further include obtaining questionnaire data from the subject, including symptom severity, symptom improvement, and / or user satisfaction, after at least a portion of the first treatment phase (e.g., after at least one day of pelvic floor muscle exercise treatment). The location data from the one or more sensors and the questionnaire data are processed to establish a performance metric. In some embodiments, the likelihood of treatment success may be 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 a 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 different from the first therapy.

[0033] definition Unless otherwise stated, as used herein, the singular forms “a”, “an” and “the” include plural indicators.

[0034] As used herein, the terms “about” and “approximately” mean + / - 10% of the stated value.

[0035] As used herein, the terms “near” and “adjacent” refer to locations near the tissue surface (e.g., approximately 0.01–5 mm from the tissue surface, or immediately adjacent to the tissue surface, such as around the subject’s cervix or vaginal stump).

[0036] As used herein, the term "feedback" or "biofeedback" refers to information that can be used to train a subject to modify physiological activities (e.g., pelvic floor muscle function) with the aim of improving health and performance (e.g., treating, alleviating, and / or preventing the occurrence or symptoms of pelvic floor dysfunction (PFD)). Biofeedback may also include information collected by sensors of a device (such as an intravaginal device) during routine monitoring, such as information collected substantially in real time as the user performs daily activities or pelvic floor muscle exercises. This information can be reviewed substantially in real time or can be accessed for later review. Presenting this information to the subject can be transmitted via visual, auditory, or tactile signals.

[0037] As used herein, the term “diagnosis” refers to the identification or classification of a disease or symptom (e.g., pelvic floor muscle dysfunction). For example, “diagnosis” can refer to the identification of a specific type of urinary incontinence.

[0038] “Symptom” is any condition that would benefit from treatment, including but not limited to chronic and acute conditions or diseases, including those pathological conditions that make a subject susceptible to the symptom in question.

[0039] As used herein, the term "monitoring" refers to the use of an intravaginal device as described herein to collect, track, and / or store data, such as data obtained from sensors of the device described herein. Monitoring can be performed, for example, when the device is positioned inside the body (e.g., placed inside the user's vaginal cavity), and / or when the device is used during diagnosis or treatment.

[0040] As used herein, the terms “pelvic floor muscle elevation” and “PFL” refer to the movement of the pelvic floor muscles (e.g., the muscle fibers of the levator ani muscle (e.g., the pubococcygeus, iliococcygeus, coccygeus, and puborectalis muscles, as well as the perineal muscles and anal sphincter) and associated connective tissue that traverses in a spherical form from the pubis anteriorly to the sacrum posteriorly and to the region of adjacent bony structures connecting these two bones), characterized by upward movement of the pelvic floor muscles (e.g., elevation movements, such as movements in the cephalic direction). During PFL, the movement of the pelvic floor muscles is a clearly described component of the synergistic action of the entire pelvic floor muscles (e.g., the levator ani, urethral sphincter, anal sphincter, bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscle), thereby producing a combined elevation and circumferential guiding effect when all muscles are activated simultaneously. PFL may involve selective engagement of the levator ani component of the pelvic floor muscles.

[0041] As used herein, the terms “pelvic floor muscle relaxation” and “PFR” refer to the movement of the pelvic floor muscles (e.g., the muscle fibers of the levator ani muscle (e.g., the pubococcygeus, iliococcygeus, coccygeus, and puborectalis muscles) and associated connective tissue that traverses in a spherical shape from the pubis anteriorly to the sacrum posteriorly and to the region of adjacent bony structures connecting these two bones), characterized by relaxation movements of the pelvic floor muscles (e.g., downward movements, such as movements in the caudal direction). The movement of the pelvic floor muscles during PFR differs from the concentric contraction (e.g., shortening contraction) of PFL and represents the elongation or relaxation of muscle fibers.

[0042] As used in this article, "real-time" refers to the actual time during which an event (such as a daily activity) occurs.

[0043] As used herein, “sensor data” refers to one or more of the following measurements: muscle (e.g., pelvic floor muscle) movement, muscle mass, muscle strength, pressure, and other conditions (e.g., pH, temperature, and / or humidity (e.g., vaginal humidity)) characterizing the health of a subject’s pelvic floor muscles, obtained by sensors as described herein, via an intravaginal device. Sensor data relating to pelvic floor muscle movement (e.g., urinary incontinence, fecal incontinence, or urinary urgency) may also be collected. This data can be used, for example, for the diagnosis and / or treatment of urinary incontinence and / or fecal incontinence.

[0044] As used in this article, "radio frequency" refers to frequencies above 10 GHz. 3 Hz to 10 12 Electromagnetic waves in the Hz range.

[0045] As used in this article, the terms “subject” and “patient” are used interchangeably to refer to mammals, such as humans.

[0046] As used herein, the terms “reduction” and “inhibition” are defined as the ability to result in a reduction of approximately 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, or more in total weight, in a measurable measure. Reduction or inhibition may refer, for example, to symptoms of pelvic floor dysfunction (PFD) that is being treated.

[0047] As used herein, the term “questionnaire” refers to a set of one or more questions presented by a user regarding the state or severity of their pelvic floor dysfunction (e.g., the state or severity of their symptoms or the state of improvement of their symptoms). These questions may include yes or no answers, or may ask the user to rate their symptoms or outcomes on a relative scale (e.g., 0 to 5 or 0 to 10). A questionnaire may include, for example, a Urinary Disturbance Scale (UDI-6) survey and / or other assessments of whether the subject has achieved a Patient Acceptable Symptom State (PASS). A PASS may be based on the subject’s symptom level according to a symptom scale (e.g., the scale used in the UDI-6 survey), or may include a survey question such as “Considering the different impacts of urinary incontinence on you, do you consider your current state satisfactory?”. A PASS is a threshold score at which a patient considers their state satisfactory and is likely no longer seeking or needing treatment. If a patient reaches a certain level on a symptom scale and / or answers “yes” to the questionnaire question “Considering the different impacts of urinary incontinence on you, do you consider your current state satisfactory?”, the patient may be considered to have achieved a PASS. UDI-6 surveys are described, for example, by Skorupska et al., ( Health Qual Life Outcomes The UDI-6 (19:87, 2021) consists of six items: 1- Urinary frequency, 2- Urinary incontinence due to urgency, 3- Urinary incontinence due to activity, 4- Small amount of urinary incontinence (a few drops) when coughing or sneezing, 5- Difficulty urinating, and 6- Pain or discomfort in the lower abdomen or genital area. A higher score on the UDI-6 indicates a greater degree of dysfunction, and the total score ranges from 0 to 100.

[0048] As used herein, the term “treatment” refers to providing a therapy to a subject in need (e.g., to treat or reduce the likelihood of urinary incontinence or fecal incontinence or related urinary urgency), specifically in conjunction with the use of the vaginal devices, systems, or methods described herein. “Treating a disease” or “for therapeutic treatment” includes administering treatment to a subject who already has a disease to improve or stabilize the subject’s condition. “Preventing a disease” or “reducing the likelihood of developing a disease” refers to preventive treatment to a subject who does not yet have a disease or does not yet have symptoms but is at risk of developing or otherwise has a specific disease (such as urinary incontinence or fecal incontinence or pelvic organ prolapse).

[0049] As used herein, “female urogenital system” refers to the following organ systems: the female reproductive system, including, for example, Bartholin's glands, cervix, clitoris, frenulum of the clitoris, clitoral glans / glans clitoridis, clitoral prepuce, fallopian tubes, labia majora, labia minora, frenulum of the labia minora, ovaries, Skene's glands, uterus, vagina, and vulva; the urinary system, including, for example, kidneys, ureters, bladder, and urethra; and surrounding and supporting nerve and muscle tissues.

[0050] As used in this article, "vaginal stump" refers to the sutured tissue remaining at the top of the vaginal canal after the removal of the cervix (e.g., during a hysterectomy).

[0051] As used in this article, "urinary incontinence" refers to the leakage of urine from the bladder. The degree of urinary incontinence can range from leakage of only a few drops to complete bladder emptying. Urinary incontinence can be classified into three main types: stress urinary incontinence (SUI), urge urinary incontinence, and mixed urinary incontinence. Stress urinary incontinence refers to leakage of urine when coughing, laughing, or sneezing. Leakage may also occur when the subject (e.g., a female subject) walks, runs, or exercises. Urge urinary incontinence refers to a sudden, uncontrollable, and intense urge to urinate. Women with this type of incontinence may leak urine while on their way to the bathroom. Mixed urinary incontinence combines the symptoms of both stress and urge urinary incontinence.

[0052] As used in this article, "pelvic floor muscles" refers to the muscular region located at the bottom of the abdomen that connects to the pelvis.

[0053] As used in this article, "pelvic floor muscle dysfunction" or "PFD" refers to conditions that affect the muscles and tissues that support the pelvic organs. These conditions may lead to loss of bladder or bowel control, or may cause one or more pelvic organs to droop, resulting in prolapse. Attached Figure Description

[0054] Figure 1This is a graph illustrating the progress of pelvic floor muscle lifting exercises over time. The graph depicts the change in average lifting angle over time, shown in both days and weeks. Average lifting angle data were collected from 880 subjects who were stratified into two groups: (1) subjects who reported achieving minimum clinically significant difference and / or achieving a patient-acceptable symptom state (PASS+); and (2) subjects who reported not achieving minimum clinically significant difference and / or not achieving a patient-acceptable symptom state (PASS-). Two curves were plotted to show the change in average lifting angle over time for the two groups. The likelihood of treatment success and / or the suitability of alternative treatment options were then determined by correlating subject performance with one of the trend lines and other variables such as age, type of pelvic floor muscle dysfunction diagnosed, baseline disease severity, and duration of retention.

[0055] Figure 2 This is a diagram illustrating how the algorithm used to predict treatment success can be optimized over time as more data is fed into the model.

[0056] Figure 3 This is a set of variables associated with the predictive model. The results are from commercial data on a large cohort of women with urinary incontinence (approximately 950 women). This figure illustrates the variables associated with successful treatment and how the likelihood of success can be predicted after 2 weeks of using the vaginal device.

[0057] Figure 4 This diagram illustrates how increasing compliance can improve the likelihood of success in the case of no initial responders. Detailed Implementation

[0058] This article describes methods for treating pelvic floor muscle dysfunction (e.g., urinary incontinence) and for monitoring pelvic floor muscle therapy. A key feature of this article is the method for determining the likelihood of success of pelvic floor muscle therapy, which allows users or healthcare providers to monitor treatment efficacy and adjust treatment as needed to ensure optimal outcomes.

[0059] Typically, the methods described herein employ pelvic floor muscle exercises, which include one or more pelvic floor muscle movements (e.g., lifting movements) to strengthen the pelvic floor muscles. Pelvic floor muscle exercises may include the use of an intravaginal device containing multiple position or motion sensors (e.g., microelectromechanical systems (MEMS) accelerometers) disposed along the length of the device. These sensors (e.g., accelerometers) provide real-time position and motion data that can be used to track the position of the device within the subject's vagina. Motion of the device, as detected by the accelerometer, can serve as an indicator to determine the position of the pelvic floor muscles in the subject during the pelvic floor muscle exercises.

[0060] The sensor output of one or more accelerometers reflects the vaginal angular position, and this angle is generally related to the force of the lifting motion. Therefore, a larger lifting angle corresponds to a greater lifting motion, which helps strengthen the pelvic floor muscles, thereby treating pelvic floor dysfunction. Sensor angle data generated by accelerometers in intravaginal devices are described, for example, in PCT Publications WO / 2015 / 103629 and WO / 2019 / 200222, the disclosures of which are hereby incorporated by reference in their entirety.

[0061] In many subjects, pelvic floor muscle exercise therapy has been effective in treating various pelvic floor dysfunctions. However, a subset of subjects do not respond to pelvic floor muscle exercise therapy or may require alternative treatments including modified pelvic floor muscle exercises. Therefore, pelvic floor muscle exercise therapy may not be ideal or necessary for such non-responsive subjects, as it is unlikely to produce any clinically meaningful change in their condition. Alternatively, for such non-responsive subjects, modifications to the pelvic floor muscle exercise therapy may be necessary to produce a clinically meaningful change in their condition. Therefore, the method of the present invention reflects the finding that, when using an intravaginal device with one or more position sensors, the user can track the intravaginal device over time during the initial phase of pelvic floor muscle exercise therapy. While the user performs pelvic floor muscle exercises, performance metrics can be calculated based on one or more physiological indicators generated by the sensors, such as the subject's average lifting angle or lifting duration. Tracking performance metrics over time allows algorithms to determine the likelihood of success of pelvic floor muscle exercise therapy and / or whether alternative treatment options should be considered. If a subject is likely to require pelvic floor muscle exercises, the user can continue using the vaginal device for pelvic floor muscle exercises, or the exercise program can be modified to enhance strength and performance. Alternatively, if it is determined that the therapy is unlikely to produce a clinically meaningful change in their condition, then pelvic floor muscle exercise therapy can be discontinued, and alternative therapies can be employed.

[0062] By determining the likelihood of success early in the treatment regimen, the approach described in this paper reduces the time wasted on trying therapies that are unlikely to succeed, while optimizing treatment regimens for users who have shown meaningful clinical benefits from pelvic floor muscle exercises, without resorting to unnecessary or more invasive treatment options (such as surgery).

[0063] Establish performance metrics The methods described herein include collecting data (such as location data and / or questionnaire data) to establish performance metrics. These methods may include obtaining location data from one or more sensors of an intravaginal device, for example, when the device is used during one or more pelvic floor muscle exercises (e.g., pelvic floor muscle lift) during a data collection phase. The data collection phase may be from 1 day to 16 weeks (e.g., 1 day to 12 weeks, such as 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 implementations, the data collection phase is 1 to 2 weeks (e.g., 7, 8, 9, 10, 11, 12, 13 or 14 days).

[0064] Positional data obtained by the methods described herein may include sensor angles and / or time. Performance metrics may be a function of, or related to, these sensor angles and time. For example, performance metrics may include one or more of the following: average lifting angle, average lifting duration, lifting frequency, or combinations thereof (e.g., a comprehensive score including one or more of the following: average lifting angle, average lifting duration, and lifting frequency). The intravaginal device may include multiple sensors (e.g., microelectromechanical systems (MEMS) accelerometers) positioned along the length of the device, and sensor angle data may be obtained from these accelerometers. Performance metrics may also include scores or weighting coefficients that include one or more of the following from the subject: demographic, physiological, or medical history data, including, for example, weight, medical history, race, exercise level, reproductive history, income level, occupation, etc. Such data may be provided directly by the subject, caregiver, or medical record.

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

[0066] The questionnaire may include, for example, a Urinary Distress Scale-6 (UDI-6) survey and / or other assessments of whether the subject has achieved a Patient Acceptable Symptom State (PASS). Questionnaire data can be obtained prior to the data collection phase and after at least one day of pelvic floor muscle training therapy. Collecting more than one data point allows for tracking changes in the progress of survey questions (e.g., “Considering the different impacts of urinary incontinence on you, do you consider your current state satisfactory?”). PASS is a threshold score below which a patient considers their state satisfactory and is likely no longer seeking or needing treatment. If a patient reaches a certain level on the symptom scale and / or answers “yes” to the questionnaire question “Considering the different impacts of urinary incontinence on you, do you consider your current state satisfactory?”, the patient can be considered to have achieved PASS.

[0067] The method described herein includes establishing a performance metric by combining physical data (e.g., objective data) and survey data (e.g., subjective data), and processing the data to generate, for example, a composite score. Processing steps may include processing the location data from the one or more sensors and the questionnaire data to establish the performance metric. The performance metric may be a composite score that includes an average elevation angle and a PASS score or other symptom assessment score, and may be weighted by other variables such as age, weight, medical history, race, exercise level, reproductive history, income level, occupation, type of diagnosed pelvic floor dysfunction, disease severity, and adherence to a pelvic floor exercise program, or in combination with other variables. The composite score may include, for example, an average elevation angle, an average elevation duration, and a PASS score or other symptom assessment score. Once this data is collected, it can be compared to predetermined thresholds for the performance metric to establish the probability of success. For example, the performance metric may be compared to historical data (e.g., from a previously treated population of subjects) to determine the probability of success.

[0068] If subjects achieve a certain overall score and / or a certain elevation angle and / or elevation duration, this is likely strongly correlated with positive treatment outcomes. Furthermore, progress in pelvic floor muscle exercises—i.e., consistent performance indicating the average elevation angle in healthy or treated subjects, or a trend line consistent with achieving such outcomes—will be an important factor in determining the likelihood of success of pelvic floor muscle therapy and / or whether alternative treatment options should be considered. Alternatively, if subjects fail to achieve a certain overall score, and / or their average pelvic floor muscle elevation angle remains consistently below average, or follows a trend line consistent with that of subjects who did not achieve positive treatment results, this may indicate that pelvic floor muscle therapy is unlikely to be successful.

[0069] like Figure 2As shown, the algorithm can be optimized over time as more data is fed into the model. Multiple coefficients are weighted based on their correlation 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 scheme. The algorithms described in this paper include regressions involving both linear and logistic regression. Once the historical data has been initially analyzed, the model is trained (improved / refined) and tested using additional existing data. This tests the model's predictive ability on new data not used to create the initial model. Once the model is optimized in terms of sensitivity and / or specificity, it can be used to predict individual-level prognoses for new patients. The choice of sensitivity and specificity (false negatives or false positives) is determined based on the intended use of the model. For example, if the model is to be used to influence coaching, then minimizing the number of false negatives is a concern. If the model is to be used as a predictive tool for surgery, then eliminating false negative results will be a priority.

[0070] Weighting can be determined by analyzing historical datasets, training and validating on new datasets, and then applying it to individuals. Weighting can also be determined through regression analysis, which aims to achieve the best "fit" for all variables to provide the most predictive regression model. Exemplary weighting curves and variables are shown in... Figure 3 And in Tables 1 and 2. Figure 4 It demonstrates how improved compliance can increase the likelihood of success.

[0071] Treatment The method described herein employs the performance metrics described above. For example, this document features a method for treating pelvic floor muscle dysfunction by determining the likelihood of treatment success. The method includes the step of obtaining location data from one or more sensors of an intravaginal device used during one or more pelvic floor muscle exercises during a first treatment phase of a first therapy. The method may further include processing the location data from the one or more sensors to establish a performance metric, thereby determining the likelihood of treatment success of the first therapy. The likelihood of treatment success can be positive or negative. The method may further include obtaining questionnaire data from the subject, including symptom severity, symptom improvement, and / or user satisfaction, after at least a portion of the first treatment phase (e.g., after at least one day of pelvic floor muscle exercise treatment). The processing steps may include processing the location data from the one or more sensors and the questionnaire data to establish a performance metric. If the performance metric is above a predetermined threshold, the likelihood of treatment success can be positive. Alternatively, if the performance metric is below a predetermined threshold, the likelihood of treatment success is negative. If the performance metric is above the predetermined threshold, the method may further include, for example, continuing treatment during a second treatment phase of the first therapy. If the performance metric falls below a predetermined threshold, the method may further include administering a second therapy different from the first therapy. The method described herein includes collecting performance data during this first treatment phase, and this data may be processed to compare with historical data (e.g., from a group of subjects who previously received the treatment) to determine the likelihood of success and / or whether alternative treatment options should be considered. The performance metric may be a composite score that includes average lifting angle and symptom assessment score, and may be weighted by other variables such as age, weight, medical history, race, exercise level, reproductive history, income level, occupation, disease severity, and adherence to the pelvic floor muscle exercise program. The composite score may include average lifting angle, average lifting duration, and symptom assessment score.

[0072] A further feature is a method for determining a predetermined threshold for a performance metric based on location data from a pelvic floor muscle exercise therapy. The method includes acquiring location data from one or more sensors installed intravaginally during pelvic floor muscle exercises at the start of a first treatment phase of the first therapy. The method further includes obtaining questionnaire data from the subject regarding symptom severity, symptom improvement, and / or user satisfaction after at least a portion of the first treatment phase (e.g., after at least one day of pelvic floor muscle exercise therapy). The method may also include processing the location data from the one or more sensors and the questionnaire data to establish the predetermined threshold for the performance metric.

[0073] Position data obtained by the methods described herein may include sensor angles and / or time. Performance metrics may be a function of, or related to, these sensor angles and time. For example, performance metrics may include one or more of the following: average lifting angle, average lifting duration, lifting frequency, or combinations thereof (e.g., a comprehensive score including one or more of the following: average lifting angle, average lifting duration, and lifting frequency). The intravaginal device may include multiple sensors (e.g., microelectromechanical systems (MEMS) accelerometers) positioned along the length of the device, and sensor angle data may be obtained from these accelerometers.

[0074] Data processing may include processing data from questionnaires that include ratings or questions related to symptom severity, symptom improvement, and / or user satisfaction. Questionnaires may include, for example, a Urinary Disturbance Scale (UDI-6) survey and / or other assessments of whether the subject has achieved a Patient Acceptable Symptom State (PASS). Questionnaire data may be obtained before the start of the first phase of the first therapy and after at least a portion of the first phase (e.g., after at least one day of pelvic floor muscle training). Collecting more than one data point allows for tracking changes in the progress of survey questions (e.g., “Considering the different effects of urinary incontinence on you, do you consider your current state satisfactory?”). PASS is a threshold score below which a patient considers their state satisfactory and is likely no longer seeking or needing treatment. If a patient reaches a certain level on the symptom scale and / or answers “yes” to this question, the patient may be considered to have achieved PASS. The UDI-6 survey is described, for example, by Skorupska et al., (… Health Qual Life Outcomes The reference mentioned in (19:87, 2021) is incorporated herein by reference. The Symptom Status Scale (PASS) can be used as a subjective measure of patient treatment in women with urinary incontinence (see, for example, Sanderson et al., 19:87, 2021). Female Pelvic Medicine and Reconstructive Surgery (Reference 28:1, 33-39, 2021), which is incorporated herein by reference. Subjects' UDI-6 scores before treatment may be greater than or equal to 37.5. Subjects' UDI-6 scores after treatment may be less than or equal to 37.5.

[0075] Data processing may include processing data on subject adherence to the first phase of treatment. For example, if a subject is non-adherent, the data or performance metrics may be weighted by coefficients corresponding to how strictly the subject adhered to the treatment regimen (e.g., 0 for non-adherence and 1 for adherence). Performance metrics may vary with time (e.g., metrics may increase linearly with time, for example, as subject performance improves). The processing may include linear regression analysis on positional data (e.g., for determining ramps) or the duration of lifts performed by the subject (e.g., for determining time associated with a certain lift angle or ramp). Predetermined thresholds and / or performance metrics may vary with the subject's age, the type of pelvic floor dysfunction diagnosed, and / or the severity of the pelvic floor dysfunction. Data processing may also include analyses from one or more of the following: demographic, physiological, or medical history data, such as weight, medical history, race, exercise level, reproductive history, income level, occupation, etc. Such data may be provided directly by the subject, caregivers, or medical records.

[0076] The method described herein includes treating a subject for pelvic floor muscle dysfunction. The method may include the step of obtaining positional data from one or more sensors of an intravaginal device used during one or more pelvic floor muscle exercises during a first treatment phase of a first therapy. The method may further include processing the positional data from said one or more sensors to establish a performance metric. The method may further include continuing treatment for pelvic floor muscle dysfunction during a second treatment phase of the subject's first therapy, e.g., where the performance metric is above a predetermined threshold. Alternatively, the method may include performing a second therapy different from the subject's first therapy, e.g., where the performance metric is below a predetermined threshold.

[0077] Other methods considered herein include treating pelvic floor dysfunction in subjects who do not respond to a first therapy (e.g., a first therapy including pelvic floor muscle exercises). The method may include treating the subject with a second therapy different from the first therapy. Previously, a subject's lack of response to the first therapy has been determined by obtaining positional data from one or more sensors of the intravaginal device used during one or more pelvic floor muscle 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 that determines the likelihood of success of the first therapy. A subject may also be identified as non-responsive by determining that the performance metric is below a predetermined threshold.

[0078] Position data obtained by the methods described herein may include sensor angles and / or time. Performance metrics may include, for example, average lift angle, average lift duration, lift frequency, or combinations thereof (e.g., a comprehensive score including one or more of the following: average lift angle, average lift duration, and lift frequency).

[0079] The first treatment phase can be from 1 day to 16 weeks (e.g., 1 day to 12 weeks, such as 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 implementations, the first treatment phase is 1 week to 2 weeks (e.g., 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, or 14 days). Data collection can be conducted throughout or in part of the first treatment phase (e.g., data collection can be conducted multiple times a day, once a day, once or more every other day, once or more every three days, once or more every week, etc.).

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

[0081] The second treatment phase can range from 1 day 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 can also range 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 can continue until one or more symptoms of the pelvic floor muscle dysfunction are reduced or eliminated.

[0082] like Figure 1As shown, the progress of pelvic floor muscle lifting exercises gradually increases over time, as measured by the average lifting angle. When a subject typically begins pelvic floor muscle exercise therapy, she exhibits an initial burst of progress during the initial learning phase. Subsequently, the increase in average lifting angle continues linearly, but the slope decreases. Eventually, as the user approaches the maximum average lifting angle, their progress may plateau. As discussed in Example 1, and in... Figure 1 The study collected data on the mean lift angle over time from 880 participants, presented in both daily and weekly units. Participants were stratified into two groups: (1) those who reported achieving minimum clinically significant difference and / or a patient-acceptable symptom state (PASS+), and (2) those who did not report achieving minimum clinically significant difference and / or a patient-acceptable symptom state (PASS-). Two curves were plotted to illustrate the change in mean lift angle over time for both groups. The likelihood of success was then determined by correlating participant performance with one of these trend lines along with other variables such as age, weight, medical history, race, exercise level, reproductive history, income level, occupation, type of pelvic floor dysfunction diagnosed, baseline disease severity, and duration of hold.

[0083] Processing the data may include using algorithms. Processing may include using algorithms to calculate performance metrics based on changes in sensor angles over time or average lifting angles, and subjective questionnaire data (such as user assessments of whether pelvic floor muscle symptoms are acceptable). Such processing may be performed in an intravaginal device, in a peripheral device used in conjunction with an intravaginal device, on a standalone computer, or in the cloud. The processing may also include processing questionnaire data. Performance metrics may be a composite score including average lifting angles and the patient's acceptable symptom status.

[0084] In some implementations, the predetermined threshold is calculated based on a population of subjects receiving the first treatment. The subject population may include at least 50 subjects (e.g., at least 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, or more subjects). For example, the subject population may include a first subset of the subject population that has been identified as responding to the first treatment and a second subset of the subject population that has not responded to the first treatment. The predetermined threshold for the performance metric may include the minimum clinically important difference (MCID) or patient-acceptable symptom status (PASS) of the population.

[0085] Both MCID and PASS are calculated values ​​derived from psychometric assessments of hundreds of women using the UDI-6 survey. Both MCID and PASS are value / threshold values. MCID can be calculated by subtracting the most recently reported value from the baseline value to determine whether a change in the survey is likely to correspond to a clinical or experiential change. PASS is calculated as a value below which a patient may feel satisfied and no longer seek further treatment. A subject's UDI-6 score before treatment may be greater than or equal to 37.5. A subject's UDI-6 score after treatment may be less than or equal to 37.5.

[0086] Performance metrics (e.g., the subject's average lift angle or lift duration) can vary with time. For example, performance metrics (e.g., the subject's average lift angle or lift duration) can increase linearly with time, for example, as the subject improves their performance.

[0087] Performance metrics can be an average lift angle of 5° to 40°, for example, 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°). Performance metrics can be an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first week of the first therapy. Performance metrics can be an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first two weeks of the first therapy. Performance metrics may be, after the first treatment phase of the first therapy at three weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at four weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at five weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at six weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at seven weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be, after the first treatment phase of the first therapy at eight weeks, an average lift angle of 5° to 40° (e.g., 5° to 30°). Performance metrics may be performed weekly, or as needed, in relation to the subject's therapy.

[0088] Performance measures can be the duration a subject can maintain an upward lift at a certain upward 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°). Performance measures can also be the duration of a subject maintaining an upward lift at an average upward angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first week of the first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a two-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a three-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a four-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a five-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a six-week first therapy. Performance metrics can be the duration of an average lift angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of a seven-week first therapy. Performance metrics may be the duration of an average lifting angle of 5° to 40° (e.g., 5° to 30°) after the first treatment phase of the first eight-week first therapy. Performance metrics may be performed weekly or, as needed, as part of the subject's therapy. The first treatment phase may include a defined set of pelvic floor muscle exercises. For example, the first treatment phase may include alternating pelvic floor muscle lifts and pelvic floor muscle relaxations. For example, the first treatment phase may include performing a 15-second pelvic floor muscle lift and a 15-second pelvic floor muscle relaxation. The pelvic floor muscle lifts and pelvic floor muscle relaxations may be repeated once or multiple times (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more times). For example, pelvic floor muscle lifts and pelvic floor muscle relaxations may be repeated five times for a duration of 2.5 minutes. These sessions may be repeated twice daily; for example, two 2.5-minute sessions including pelvic floor muscle lifts and pelvic floor muscle relaxations may be performed daily. Data can be graphically or computationally analyzed over time to correlate performance metrics with predetermined thresholds, for example, by performing linear regression to establish a trend line for expected performance.

[0089] In one implementation, based on the subject population, linear regression is performed between two trend lines corresponding to the average lift angle of PASS(+) or PASS(-). The linear regression yields the following equation: PASS(+) y=7.22 + 2.85 * log(x) PASS(-) y=7.82 + 1.97 * log(x) The y-intercept and slope of the PASS(+) trend line are both higher than those of the PASS(-) trend line, indicating a more significant change in the average pelvic floor muscle elevation angle during treatment. Therefore, if a subject's data point falls above the PASS(-) curve, it can be expected that the data point indicates a higher probability of success for pelvic floor muscle treatment. Conversely, if the data point is below the PASS(-) trend line, it can be expected that pelvic floor muscle treatment is less likely to be successful. The trend line can be used to establish a baseline through which subjects can be assessed according to the methods described herein. Specifically, the trend line can be used to establish a performance metric, above which subjects are identified as improving or successfully responding to the treatment regimen, and below which subjects can be identified as non-responsive or poorly responsive. Subjects identified as non-responsive or poorly responsive can choose to receive more intensive treatment according to the first treatment regimen, or they can choose to receive treatment according to a second treatment regimen (e.g., a different regimen from the first). After successfully completing the second treatment regimen, this subject can be re-enrolled in a subsequent treatment regimen (similar or identical to the first treatment regimen). The subject's responsiveness to treatment can be reassessed by comparing it to a trend line to determine whether the subject has successfully responded to the treatment. If not, a more aggressive treatment approach (e.g., surgery) may be necessary.

[0090] 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 from the first treatment phase of the first therapy. In some embodiments, the second treatment phase includes one or more pelvic floor muscle lifts with increased frequency, duration, and / or intensity relative to the first treatment phase of the first therapy. For example, pelvic floor muscle lifts may be performed for longer holding times, at faster intervals, or during more frequent exercise sessions throughout the day. Following this adjustment to the therapy, performance metrics may continue to be monitored to determine the likelihood of success of the modified therapy.

[0091] The second therapy may differ from the first therapy. The second therapy may include one or more pelvic floor muscle lifts with increased frequency, duration, and / or intensity relative to the first therapy. If pelvic floor muscle exercise therapy is not an effective treatment option, the second therapy may include alternative treatments such as electrical stimulation therapy, anticholinergic or beta-agonist therapy, use of a pessary for urinary incontinence, peripheral nerve modulation, tibial nerve modulation, sacral nerve modulation, perurethral padding, intravaginal balloon or other prosthetic or surgical interventions (e.g., mid-urethral suspension, rectus abdominis fascia suspension, Butch vaginal suspension, or Marshall Marchetti-Krantz (MMK) vaginal suspension).

[0092] The method described herein may further include determining a performance metric during a second therapy or a second phase of a first therapy. For example, the method may further include (i) obtaining positional data from one or more sensors of an intravaginal device used during the one or more pelvic floor muscle lifts performed during the second therapy; and (ii) processing the positional data from the one or more sensors to establish a second performance metric thereby determining the likelihood of success of the second therapy.

[0093] If the second performance metric is above a predetermined threshold, the method may include continuing treatment for the pelvic floor muscle dysfunction during a second treatment phase of the second therapy. In other embodiments, if the second performance metric is below the predetermined threshold, the method includes performing a third therapy different from the second therapy.

[0094] The methods described herein may also include, for example, interrupting treatment when one or more symptoms of the pelvic floor muscle dysfunction are relieved or disappear.

[0095] Any method described herein can be implemented using a peripheral device, for example, one that works in conjunction with an intravaginal device to monitor and track treatment progress. For example, the performance metric can be displayed on the peripheral device, which includes a computer processing unit configured to receive and process data from one or more sensors of the intravaginal device. The peripheral device can display, for example, the progress of the performance metric over time. The peripheral device may include audio and / or visual alarms to provide feedback to the subject. The peripheral device may include settings for, for example, personalizing the operation of the intravaginal device on the subject relative to the performance metric.

[0096] Peripheral devices The systems and methods described herein can employ peripheral devices. Peripheral devices can be any suitable electronic device, such as a computer, smartphone, tablet, or smartwatch. Peripheral devices can be programmed with software or mobile applications to facilitate use in conjunction with the devices and systems described herein. Peripheral devices can be configured with a processing unit that can convert or utilize sensor data received from the intravaginal device. For example, when a subject performs pelvic floor muscle exercises during daily activities (e.g., activities that alter (e.g., increase and / or decrease) the overall health of their urogenital system and / or pelvic floor muscles), sensor data can be received to provide feedback to the subject regarding whether the detected activity affects their health or indicates treatment or the need for treatment of pelvic floor muscle dysfunction (such as urinary incontinence and / or fecal incontinence).

[0097] 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 one or more pelvic floor muscle elevations during a first treatment phase of the 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 the likelihood of success of the first therapy. The peripheral device may be further configured to instruct the user to continue treatment for the pelvic floor dysfunction during a second treatment phase of the first therapy on the subject, wherein the performance metric is above a predetermined threshold; or to instruct the user to administer a second therapy to the subject different from the first therapy, wherein the performance metric is below the predetermined threshold.

[0098] The peripheral device may be further configured to obtain questionnaire data from the subject, including symptom severity, symptom improvement, and / or user satisfaction, after at least a portion of the first treatment phase, for example, by inputting it into a graphical user interface. The peripheral device may be further configured to process the location data from the one or more sensors and the questionnaire data to establish performance metrics.

[0099] The peripheral device may be, for example, a smartphone or tablet computer. The peripheral device may include a graphical user interface, such as a touchscreen graphical user interface. The peripheral device may be configured to perform methods as described herein, such as the methods in any of the embodiments described above.

[0100] The peripheral device may be part of a system that includes the peripheral device as described herein and an intravaginal device, the intravaginal device including one or more sensors (e.g., a MEM accelerometer, for example, positioned along the length of the device). The peripheral device may include settings for personalized operation of the intravaginal device on the subject, for example, relative to the performance metric.

[0101] The peripheral device can process sensor data to generate a baseline that can be used to compare with sensor data acquired at future times to provide feedback (e.g., alerts) to the subject regarding whether the activity performed is beneficial or detrimental to their health, or whether pelvic floor muscle exercises indicate treatment or the need for treatment of pelvic floor dysfunction. Alternatively or additionally, the peripheral device can process sensor data and compare the results with a previously established or predetermined baseline (e.g., based on the subject's previous performance or the average of a subject group), and can provide feedback (e.g., alerts) to the subject based on the comparison regarding whether the activity performed is beneficial or detrimental to their health, or whether pelvic floor muscle exercises indicate treatment or the need for treatment of pelvic floor dysfunction. Additionally, the peripheral device may include a user interface. The user interface can be programmed to display data and / or provide instructions for use of the intravaginal device.

[0102] Peripheral devices can be equipped with Wi-Fi or internet connectivity. For example, peripheral devices can be able to transmit data from sensors to cloud-based, web-based servers or other information storage solutions.

[0103] The peripheral device can be configured to receive sensor data from the intravaginal device to monitor, for example, in essentially real-time (e.g., using one or more sensors as described herein) the user's overall health status, including the user's urogenital system and pelvic floor muscles (e.g., muscle fibers of the levator ani muscle (e.g., pubococcygeus, iliococcygeus, coccygeus, puborectalis muscles and associated connective tissue) as the user performs their daily activities. For example, the intravaginal device can be configured to detect when the user performs daily activities that alter (e.g., improve and / or decrease) the overall health status of their urogenital system and / or pelvic floor muscles, and can provide feedback to the user, for example, regarding how the detected activities affect their health status (e.g., basic...). (The average lifting angle or lifting duration of the subject). Alternatively, the peripheral device may be configured with a processing unit that can convert or utilize sensor data received from the intravaginal device during the user's daily activities to provide feedback to the user (or healthcare provider) regarding whether the detected activities affect their health. For example, the peripheral device may process the sensor data to generate a baseline that can be used to compare with sensor data obtained at a future time to provide feedback (e.g., an alert) to the user regarding whether an event (e.g., an activity she performs during daily life, such as pelvic floor muscle exercises) is beneficial or detrimental to her health.

[0104] Alternatively or concurrently, the peripheral device may process sensor data and compare the results to a previously established or predetermined baseline, and may provide feedback (e.g., alerts) to the user based on the comparison, regarding whether an event (e.g., an activity she performs during daily life, such as pelvic floor exercises) is beneficial or detrimental to her health. The user may review the feedback substantially in real time (e.g., the user may receive alerts about her health status or changes in her health status), or she may review the feedback at a later time of her own choosing, for example, by accessing the feedback stored in the memory of the intravaginal device, the memory of the peripheral device (e.g., a computer connected to or potentially connected to the intravaginal device, a mobile phone (e.g., as an alert, email, or text message), or a tablet computer), and / or the memory of a remote electronic device (e.g., a location web and / or cloud-based database connected to the intravaginal device).

[0105] Feedback may be presented as a summary (e.g., as one or more graphs) showing how a user's daily activities and muscle movements (e.g., PFL and / or PFR), muscle mass, or muscle strength, for example, change with the subject's average lifting angle or lifting duration. Daily monitoring as described herein can help users optimize treatment to avoid the development and / or recurrence of PFD or its associated symptoms, and / or inform users about the development and / or progression and / or treatment status of additional symptoms or conditions of the female pelvic floor muscles or urogenital tract.

[0106] Pelvic floor muscle exercises The pelvic floor muscles (PF), also known as the pelvic floor diaphragm, are primarily formed by the muscle fibers of the levator ani muscles (e.g., the pubococcygeus, iliococcygeus, coccygeus, and puborectalis muscles) and their associated connective tissue, which spans the area below the pelvis (Bharucha). Neurogastroenterol Motil (18:507–519, 2006). Pelvic floor muscle lifting (PFL) is an exercise characterized by upward movement of the pelvic floor muscles (e.g., lifting movements, such as movements in the cephalic direction). A closely related exercise involving relaxation of the pelvic floor muscles (e.g., downward movements, such as movements in the caudal direction) is pelvic floor muscle relaxation (PFR). The movement of the pelvic floor muscles during PFL and / or PFR can differ from the movement of the pelvic floor muscles during Kegel exercises. Kegel exercises, developed by Dr. Arnold Kegel, can be described as contractions of the vaginal canal (e.g., squeezing movements of the vaginal walls, such as movements of the vaginal walls in the dorsoventral or anterior-posterior direction). During PFL and PFR, the pelvic floor muscles can be described as lifting and lowering the vaginal cavity, respectively. This lifting or lowering of the vaginal cavity during PFL and PFR is likely due to the lifting and relaxation of the pelvic floor muscles.

[0107] Proper execution (e.g., accurate implementation) of PFL and / or PFR can be used to prevent pelvic floor muscle injury during pelvic floor muscle training (PFMT). Individual contraction of the pelvic floor muscles, such as through improper Kegel exercises, can strain, damage, or otherwise reduce the effectiveness of PFMT combined with PFL and / or PFR. Specifically, tension may be generated when a patient exerts maximum effort, which may lead to further damage to the pelvic floor muscles. Therefore, to obtain maximum therapeutic benefit and improve the efficacy of PFMT combined with PFL and / or PFR, the intravaginal device of the present invention is configured to sense and provide feedback on the accurate execution of PFL and / or PFR, and can be used in conjunction with PFL and / or PFR training as a treatment or preventative treatment for PFD (e.g., to reduce the occurrence and / or severity of at least one symptom of PFD).

[0108] PFL and / or PFR can be identified and measured using an intravaginal device as described herein, which places a sensor within the vaginal cavity of an individual, for example, proximal to the cervix or vaginal stump. The sensor, positioned proximal to the cervix or vaginal stump, is configured to detect cephalad movement of the pelvic floor muscles (e.g., PF lifting and / or relaxation movements) to detect (e.g., measure) the performance and quality of PFL and / or PFR performed by the subject.

[0109] vaginal devices The intravaginal device used in the systems and methods described herein may be an intravaginal device containing one or more sensors (e.g., position or motion sensors). The intravaginal device may be elongated (e.g., linear or cylindrical configuration) and configured to fit within the vagina of a female subject. The shape of the device may include a ring-shaped body and a tether extending from the body. The intravaginal device may be used as part of a system for monitoring pelvic floor muscle movements during, before, or after daily activities, and during diagnostic procedures. The device may be inserted into the vagina of a female subject such that it is positioned proximal to the cervix or vaginal stump. The intravaginal device may contain one or more position or motion sensors (e.g., MEMS accelerometers) and / or other sensors. The position and / or other sensors provide sensitive position and / or other information that can be used to sensitively monitor pelvic floor muscle movements and / or assess the subject's pelvic floor muscle architecture or other health aspects.

[0110] Specifically, the intravaginal device can be used during daily activities or diagnostic procedures to detect patterns of angular changes. For example, during diagnostic testing, specific sensors within the intravaginal device can be monitored to assess the pattern and angular changes of the pelvic floor muscles as an indicator of their physiological condition. These pattern and angular changes can be compared to those observed in the tested subject before diagnosis or treatment, or in subjects with known pelvic floor dysfunction (e.g., urinary incontinence or pelvic organ prolapse), to accurately diagnose pelvic floor dysfunction in the tested subject. The device can also be used to treat female subjects with pelvic floor dysfunction. When a female patient performs pelvic floor exercises with the device, the position of the pelvic floor muscle tissue can be monitored during the exercise to ensure she is exercising correctly and maintaining pelvic floor muscle activation for a sufficiently long duration (e.g., holding or lifting).

[0111] Trends and patterns of angular changes in sensors (e.g., MEMS accelerometers) observed in intravaginal devices during monitoring can be used to diagnose or predict disease states or assess the efficacy of treatments chosen by subjects based on the position, movement, and relative orientation of pelvic floor muscles (e.g., various levator ani muscles and anal sphincter groups) and / or pelvic floor organs.

[0112] Exemplary intravaginal devices, systems, and methods for treating, training, visualizing, and diagnosing the health status of a subject's pelvic floor muscles have been described in detail in PCT Publications WO / 2013 / 116310, WO / 2015 / 103629, WO / 2018 / 023037, WO / 2019 / 084469, WO / 2019 / 084468, WO / 2019 / 200222, and WO / 2019 / 200222. The disclosures in WO / 2020 / 092343 and WO / 2021 / 236768, as well as U.S. Design Patents D898911, D956,229, D958,987, D897530, D899593, D922,575, D888948, D888949, D889649, D896958, and D896,959, are hereby incorporated by reference in their entirety. Exemplary devices include the LEVA® and LIFT® pelvic floor muscle health devices. The LEVA® intravaginal device has an elongated body configured to fit within the vagina. The device contains a substantially cylindrical elongated body in which six accelerometers are mounted on a flexible printed circuit board within the device. The device is described and illustrated, for example, in PCT Publications WO 2013 / 116310 and WO 2015 / 103629, and U.S. Design Patents D898911, D956,229, and D958,987. The LIFT® device includes a loop attached to a linear tether. The LIFT® device and related devices containing loops and tethers are described, for example, in PCT Publications WO / 2018 / 023037, WO / 2019 / 084469, WO / 2019 / 084468, WO / 2019 / 200222, WO / 2020 / 092343 and WO / 2021 / 236768, and U.S. Design Patents D897530, D899593, D922,575, D888948, D888949, D889649, D896958 and D896,959.

[0113] The intravaginal device may include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) position sensors configured to detect muscle movements, such as PFL and / or PFR. In some cases, the sensors (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) may be selected from the group consisting of: motion sensors, orientation sensors, gyroscopes, microelectromechanical systems (MEMS) sensors (e.g., MEMS accelerometers), G-sensors, tilt sensors, rotation sensors, pressure sensors, light detection sensors (such as LiDAR sensors), EIM sensors, and combinations thereof.

[0114] The intravaginal device may further include a microcontroller for receiving data from a sensor. The microcontroller may also be configured or may include a separate component for non-temporary storage of data from the sensor. The microcontroller may be connected to the sensor via, for example, wires and / or a circuit board. The wires and circuit board may be flexible or rigid (e.g., a flexible printed circuit board).

[0115] The intravaginal device may also include a transmitter and receiver formed within the device 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), for example, via a relay device. Alternatively, the transmitter and receiver may be positioned within an external housing and connected to the intravaginal device wirelessly or via a detachable cable. The transmitter and receiver may be directly or indirectly connected to a microcontroller, sensor, and / or circuit board. The transmitter and receiver may be configured for use with a radio frequency (RF) transceiver. The transmitter and receiver may communicate with the transceiver, for example, using BLUETOOTH® Low Power (BLE), Industrial, Scientific, and Medical (ISM), Medical Implantable Communication Services (MICS), Wi-Fi, or RF. Information collected by the sensors may be transmitted wirelessly (e.g., downloaded, transmitted) to a peripheral device via the transmitter and receiver, for example, via an RF transceiver relay device and / or via a detachable cable.

[0116] 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 sensors, transmitters, receivers, and circuit boards.

[0117] Systems and Kits The devices and components described herein may be provided as part of a kit or system. For example, the systems and kits described herein may include one or more of the following: an intravaginal device, a peripheral device, a radio frequency transceiver, one or more sensors, a microcontroller, a transmitter, a receiver, etc. If packaged as a kit, the kit may further include its instructions for use. 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., a smartphone) may further include a mobile application or a web-based application.

[0118] database The database may reside on a local electronic device (e.g., a peripheral device such as a computer, mobile phone, or tablet) or on a remote electronic device that can communicate via the Internet (e.g., a web-based and / or cloud-based database). The database may be a central database that collects, stores, and performs calculations on sensor data collected from the intravaginal device used by the subject. Sensor data, along with additional data provided by the individual (e.g., information provided by the individual regarding symptoms of pelvic floor dysfunction, such as responses to questionnaires), may be periodically transmitted (e.g., uploaded) or stored in the database after transmission from the intravaginal device. In some cases, communication with the database is substantially continuous (e.g., during pelvic floor exercises, data uploads are substantially real-time). In other cases, communication with the database occurs hourly or daily (e.g., at least once per hour and / or at least once per day), or at user-initiated times. The database may be reviewed by the user after treatment to assess progress. Data may also be transmitted to healthcare providers (e.g., via automated transmission, transmission by a third party, or transmission by the user).

[0119] Pelvic floor muscle dysfunction The apparatus, system, and method of the present invention can be used to monitor, diagnose, and treat pelvic floor muscle dysfunction. Pelvic floor muscle dysfunction includes urinary tract disorders, which are conditions that cause difficulty in bladder storage, and urinary incontinence, which includes the body's inability to control the expulsion of urine. In walking adult women, the types and prevalence of urinary incontinence include stress urinary incontinence (SUI), detrusor instability (urge incontinence), mixed urinary incontinence (stress and urge), and other types of urinary incontinence (overflow, neurogenic). It was observed that the prevalence of detrusor instability and mixed urinary incontinence increased with age in the subject sample. Male subjects may experience similar urinary incontinence problems, which are often associated with benign prostatic hyperplasia (BPH). Men may also experience urinary retention problems due to the prostate.

[0120] Stress urinary incontinence (SI) is characterized by involuntary leakage of urine when the pressure within the bladder exceeds the maximum urethral pressure, even without detrusor muscle contraction. SI can include unintended leakage due to activities such as laughing, sneezing, coughing, or standing, as these activities increase abdominal pressure. This pressure, transmitted to the bladder and its contents, exceeds the resistance to urination generated by the urethra (and primarily the urethral sphincter). SI can be further classified as bladder neck hypermobility and intrinsic sphincter dysfunction (ISD).

[0121] Bladder neck hypermobility can be caused by pelvic floor muscle prolapse and may be attributed to weakened pelvic floor muscles and connective tissue. This can be observed concurrently with nerve damage to the external genitalia resulting from childbirth, but it can also occur in young women who have never given birth. In its normal position, the bladder is supported by pelvic floor muscles that prevent abdominal pressure from exceeding urethral pressure. When the pelvic floor muscles are weakened or damaged, the bladder neck undergoes abnormal displacement during abdominal stress, and the urethral sphincter closure pressure becomes insufficient to maintain incontinence. Urinary leakage caused by hypermobility-related bladder neck prolapse typically occurs in a cyclical manner, and the amount of urine may be proportional to the severity of the condition.

[0122] ISD is a severe form of stress urinary incontinence, which may be caused by an inherent defect in the urethral closure mechanism or by urethral dysfunction, i.e., the bladder neck is open at rest. Severe ISD results in persistent leakage of urine or leakage in response to even slight movement of the subject. In ISD, the bladder neck may be fixed or hypermobile. ISD is caused by urethral scarring resulting from previous urinary incontinence surgery in a significant proportion of cases, but it can also be caused by other reasons. Only a small percentage of subjects exhibit stress urinary incontinence caused by ISD.

[0123] Example The following examples are provided to provide a description of how the compositions and methods claimed herein can be performed, prepared, and evaluated to those skilled in the art, and are intended to be entirely exemplary in their use and not to limit the scope of what the inventors consider to be their invention.

[0124] Example 1. Predicting the likelihood of success of pelvic floor muscle training therapy Subjects with urinary incontinence underwent a series of pelvic floor muscle exercises, and their treatment progress was tracked over 12 weeks (84 days). The pelvic floor muscle exercise program consisted of alternating pelvic floor muscle lifts and relaxations, each lasting 15 seconds. This program was repeated 5 times, for a total duration of 2.5 minutes. Throughout the treatment, the 2.5-minute program was repeated twice daily.

[0125] Data points were identified by employing a sequential patient cohort treated for urinary incontinence with LEVA® (Axena Health, Inc., Boston, MA; levatherapy.com). Patients included in the analysis had a baseline Urinary Distress Scale (UDI-6) score >37.5 and had completed a baseline survey and one additional UDI-6 survey. The UDI-6 survey is described, for example, by Skorupska et al., ( Health Qual Life Outcomes In 19:87, 2021), the Symptom Status Scale (PASS) can be used as a subjective measure of patient treatment in female patients with urinary incontinence (see, for example, Sanderson et al.). Female Pelvic Medicine and Reconstructive Surgery (28:1, 33-39, 2021). PASS is assessed using the question, "Considering the various impacts of urinary incontinence on you, are you satisfied with your current state?" If the patient answers "yes" to this question, the patient is considered to have achieved PASS.

[0126] All data points were provided either through direct input (demographic data, UDI-6 survey) via the LEVA® app or through passive data collection in cases of intravaginal device use. Collected variables included adherence to the treatment regimen, mean angle change during lifting, and mean holding time of lifting.

[0127] Figure 1 The graph shown was created by plotting the daily angle values ​​for each user, averaged over the number of days of use. This graph illustrates usage over 12 weeks (84 days). A binary outcome of PASS (PASS+ or PASS-, corresponding to “satisfied” or “not satisfied”) was used, employing baseline and the most recently reported UDI-6 score (i.e., score > or < 37.5). Participants who did not provide a second score or whose baseline score was < 37.5 were not included in the analysis. Using a mixed-methods model, the difference between the two graphs showed statistical significance.

[0128] The two trend lines corresponding to the average upward angle of PASS(+) or PASS(-) are fitted in the case of linear regression, and the equation is as follows: PASS(+) y=7.22 + 2.85 * log(x) PASS(-) y=7.82 + 1.97 * log(x) The y-intercept and slope of the PASS(+) trend line are both higher than those of the PASS(-) trend line, indicating a more significant change in the average pelvic floor muscle elevation angle during treatment. Therefore, if a subject's data point falls above the PASS(-) curve, it can be expected that the data point indicates a higher probability of success for pelvic floor muscle treatment. Conversely, if the data point is below the PASS(-) trend line, it can be expected that pelvic floor muscle treatment is less likely to be successful.

[0129] A predictive model was created that uses linear regression to model the linear slope of the angle change resulting from pelvic floor muscle lifting using LEVA®. This information was used in conjunction with demographic data, usage patterns, and information on the severity of urinary incontinence, and fitted into a fully variable logistic regression model. This model was able to predict the probability of success or failure, as measured by meeting the PASS criteria, with 70% accuracy.

[0130] Example 2. Optimized Treatment Algorithm like Figure 2 As shown, the algorithm can be optimized over time as more data is fed into the model. Multiple coefficients are weighted based on their correlation 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 scheme. The algorithms described in this paper include regressions involving both linear and logistic regression. Once the historical data has been initially analyzed, the model is trained (improved / refined) and tested using additional existing data. This tests the model's predictive ability on new data not used to create the initial model. Once the model is optimized in terms of sensitivity and / or specificity, it can be used to predict individual-level prognoses for new patients. The choice of sensitivity and specificity (false negatives or false positives) is determined based on the intended use of the model. For example, if the model is to be used to influence coaching, then minimizing the number of false negatives is a concern. If the model is to be used as a predictive tool for surgery, then eliminating false negative results will be a priority.

[0131] Weighting can be determined by analyzing historical datasets, training and validating on new datasets, and then applying it to individuals. Weighting can also be determined through regression analysis, which aims to achieve the best "fit" for all variables to provide the most predictive regression model. Exemplary weighting curves and variables are shown in... Figure 3 And in Tables 1 and 2. Figure 4 It demonstrates how improved compliance can increase the likelihood of success.

[0132] Table 1: Weighting Coefficients

[0133] Table 2: Empirical Standard Error Estimates for Full Model 2

[0134] Example 3. Continue pelvic floor muscle training therapy Subjects with urinary incontinence underwent a series of pelvic floor muscle exercises, and their progress was tracked over 12 weeks. The pelvic floor muscle exercises consisted of alternating pelvic floor muscle lifts and relaxations, each lasting 15 seconds. This was repeated five times, for a total of 2.5 minutes. The 2.5-minute sessions were repeated twice daily throughout the treatment. Subjects completed the exercises using an intravaginal device to track their performance and a smartphone app to display their progress.

[0135] The subjects' baseline UDI-6 score was 40, and a baseline survey and an additional UDI-6 survey were completed after two weeks of treatment. Two weeks later, the subjects' symptoms were assessed, including whether they achieved clinical minimum significance and / or passed the test, and whether they indicated they were not fully cured and still experienced regular episodes of urinary incontinence.

[0136] After two weeks of training, performance metrics were established for the participants. The performance metrics showed that users improved their lift performance after two weeks of consistent training, consistent with the trend line of the predetermined threshold for previous participants treated with the same training protocol.

[0137] After 12 weeks of treatment, a second performance metric was established, and the user continued to show improvement in pelvic floor muscle exercises, as evidenced by an increase in the average pelvic floor muscle elevation angle. The subject's responses to the symptom questionnaire also indicated that she was receiving effective treatment and had not experienced any episodes of urinary incontinence in the past two weeks. The second performance metric suggested that the subject was nearing the end of treatment and should continue for another four weeks to further strengthen her pelvic floor muscles.

[0138] The subjects had a UDI-6 score of 20 after 12 weeks of treatment and discontinued their pelvic floor muscle exercise therapy.

[0139] Example 4. Interruption of pelvic floor muscle training therapy.

[0140] Subjects with urinary incontinence underwent a series of pelvic floor muscle exercises, and their progress was tracked over a 6-week period. The pelvic floor muscle exercises consisted of alternating 15-second pelvic floor muscle lifts and relaxations. This was repeated 5 times, for a total of 2.5 minutes. The 2.5-minute sessions were repeated twice daily throughout the treatment. Subjects completed the exercises using an intravaginal device to track their performance and a smartphone app to display their progress.

[0141] The subject's baseline UDI-6 score was 50, and a baseline survey and one additional UDI-6 survey were completed after two weeks of treatment. Two weeks later, the subject's symptoms were assessed, including whether the subject achieved clinical minimum significance and / or passed the test. The subject reported that she was not fully cured and was still experiencing regular episodes of urinary incontinence. Her condition remained severe.

[0142] After two weeks of training, performance metrics were established for the subject. These metrics indicated that the user showed no improvement in her lift after two weeks of consistent training, consistent with the trend line of the predetermined threshold for previous subjects treated with the same exercise protocol. She was unlikely to respond to treatment using the current exercise protocol.

[0143] The subject changed her pelvic floor muscle exercise program to include four 2.5-minute sessions daily. After four weeks, a second performance metric was established, and the user's performance on pelvic floor muscle exercises still did not show sufficient improvement, as evidenced by a plateau in the average pelvic floor elevation angle. The subject's responses to the symptom questionnaire also indicated that she was not receiving effective treatment, and she continued to experience episodes of urinary incontinence over the past six weeks. The second performance metric suggested that the subject was unresponsive to treatment and unlikely to be treated with pelvic floor muscle exercise therapy.

[0144] The subject scored 40 on the UDI-6 after 6 weeks of treatment and discontinued her pelvic floor muscle exercises. Her healthcare provider recommended she try alternative therapies, such as electrical stimulation, to see if her symptoms subsided.

[0145] Other implementation plans All publications, patents and patent applications mentioned in this specification are incorporated herein by reference to the same extent as each individual publication or patent application is specifically and individually indicated to be incorporated by reference.

[0146] Although the invention has been described in conjunction with its specific embodiments, it should be understood that it is capable of further modifications, and this application is intended to cover any variations, uses, or modifications of the compositions and methods used in the invention that generally follow the principles of the compositions and methods used in the invention and include deviations from this disclosure that are within the scope of known or conventional practice in the art to which this invention pertains and that may be applied to the basic features described above and are within the scope of the claims. Other embodiments are within the scope of the claims.

Claims

1. A method for treating pelvic floor muscle dysfunction in a subject, the method comprising: (a) During pelvic floor muscle exercises during the first treatment phase of the first therapy, positional data is obtained from one or more sensors installed in the vagina. (b) Processing the location data from the one or more sensors to establish a performance metric; and (c) During the second treatment phase of the subject’s first therapy, continue to treat the pelvic floor muscle dysfunction, wherein the performance metric is above a predetermined threshold; or treat the subject with a second therapy different from the first therapy, wherein the performance metric is below the predetermined threshold.

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

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

4. A method for determining predetermined thresholds for performance metrics based on location data from pelvic floor muscle training therapy: (a) During pelvic floor muscle exercises during the first treatment phase of the first therapy, positional data is obtained from one or more sensors installed in the vagina. (b) After at least a portion of the first treatment phase, obtain questionnaire data from the subject including symptom severity, symptom improvement, and / or user satisfaction; and (c) Process the location data from the one or more sensors and the questionnaire data to establish a predetermined threshold for the performance metric.

5. The method according to any one of claims 2 to 4, wherein the questionnaire includes a urinary distress scale (UDI-6) survey and / or other assessments of whether the subject has achieved a patient-acceptable symptom status (PASS).

6. The method of claim 5, wherein the questionnaire data is obtained before the first treatment phase of the first therapy and after at least a portion of the first treatment phase.

7. The method according to any one of claims 1 to 6, wherein processing the data includes processing data regarding the subject's adherence to the first treatment phase of the first therapy.

8. The method according to any one of claims 1 to 7, wherein the performance metric varies with 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 location data.

11. The method according to any one of claims 1 to 10, wherein the predetermined threshold varies with the subject's age, the type of pelvic floor muscle dysfunction diagnosed, and / or the severity of the pelvic floor muscle dysfunction.

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

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

14. The method according to any one of claims 1 to 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 1 to 12 weeks.

16. The method according to any one of claims 1 to 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 according to any one of claims 1 to 17, wherein the second treatment phase continues until one or more symptoms of the pelvic floor muscle dysfunction are relieved or disappear.

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

20. The method of any one of claims 1 to 19, wherein processing the location data includes using coefficients to weight the score based on: age, weight, medical history, race, exercise level, reproductive history, income level, occupation, type of pelvic floor muscle dysfunction diagnosed, disease severity, and / or treatment adherence.

21. The method according to any one of claims 1 to 20, wherein the intravaginal device comprises a plurality of sensors positioned along the length of the device.

22. The method according to any one of claims 1 to 21, wherein the sensor is a microelectromechanical (MEM) accelerometer.

23. The method according to any one of claims 1 to 22, wherein the predetermined threshold is calculated based on a population of at least 50 subjects receiving the first treatment.

24. The method of claim 23, wherein a first subset of the subject population has been determined to respond to the first therapy, and a second subset of the subject population has not responded to the first therapy.

25. The method of claim 23 or 24, wherein the predetermined threshold of the performance metric comprises the minimum clinically significant difference (MCID) or patient-acceptable symptom status (PASS) of the population.

26. The method according to any one of claims 1 to 25, wherein the first treatment phase comprises alternating pelvic floor muscle lifting and pelvic floor muscle relaxation.

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

28. The method of claim 26 or 27, wherein the pelvic floor muscle lifting and the pelvic floor muscle relaxation are repeated once or multiple times.

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

30. The method according to any one of claims 26 to 29, wherein the pelvic floor muscle lifting and the pelvic floor muscle relaxation are repeated twice daily.

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

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

34. The method according to any one of claims 1 to 33, wherein the second therapy comprises electrical stimulation therapy, anticholinergic or β-agonist therapy, use of a pessary for urinary incontinence, peripheral nerve modulation, tibial nerve modulation, sacral nerve modulation, perineal tamponade, intravaginal balloon or other prosthetic or surgical intervention.

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

36. The method according to any one of claims 1 to 35, further comprising: (i) Obtaining position data from one or more sensors of the intravaginal device used during the one or more pelvic floor muscle lifts performed during the second therapy; and (ii) Process the location data from the one or more sensors to establish a second performance metric to determine the likelihood of success of the second therapy.

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

38. The method according to any one of claims 1 to 37, further comprising discontinuing treatment when one or more symptoms of the pelvic floor muscle dysfunction are relieved or disappear.

39. The method according to any one of claims 1 to 38, wherein the performance metric is displayed on a peripheral device, the 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 the progress of the performance metric over time.

41. The method according to any one of claims 1 to 40, wherein the peripheral device comprises an audio and / or visual alarm that provides feedback to the subject.

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

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

44. The method according to any one of claims 1 to 43, wherein the subject's UDI-6 score after treatment is less than or equal to 37.

5.

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) Obtaining position data from one or more sensors of the vaginal device used during one or more pelvic floor muscle lifting procedures during the first treatment phase of the first therapy; and (b) Process the location data from the one or more sensors to establish a performance metric to determine the likelihood of success of the first therapy; and (c) During the second treatment phase of the subject’s first therapy, instruct the user to continue treatment for the pelvic floor muscle dysfunction, wherein the performance metric is above a predetermined threshold; Alternatively, the user may be instructed to administer a second therapy to the subject, different from the first therapy, 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 questionnaire data from the subject, including symptom severity, symptom improvement and / or user satisfaction, after 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 location data from the one or more sensors and the questionnaire data to establish the performance metric.

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

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

50. The peripheral device of claim 49, wherein the graphical user interface is a touch screen graphical user interface.

51. The peripheral device according to any one of claims 45 to 50, wherein the peripheral device is configured to perform the method according to any one of claims 1 to 30.

52. A system comprising a peripheral device according to any one of claims 45 to 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 positioned along the length of the device.

54. The system according to claim 52 or 53, wherein the sensor is a MEM accelerometer.

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

56. A method for treating pelvic floor muscle dysfunction in a subject, the method comprising: (a) Obtaining positional data from one or more sensors of an intravaginal device used during one or more pelvic floor muscle lifting procedures during the first treatment phase of the first therapy; and (b) Process the location data from the one or more sensors to establish a performance metric to determine the likelihood of success of the first therapy.

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

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

59. The method according to any one of claims 56 to 58, wherein the probability of treatment success is positive if the performance metric is higher than a predetermined threshold; or wherein the probability of treatment success is negative if the performance metric is lower than the predetermined threshold.

60. The method of any one of claims 56 to 59, wherein the performance metric is higher than 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 to 59, wherein the performance metric is below the predetermined threshold, and the method further comprises performing a second therapy different from the first therapy.

62. A method for treating pelvic floor muscle dysfunction in a subject, the method comprising: (a) During pelvic floor muscle exercises during the first treatment phase of the first therapy, positional data is obtained from one or more sensors installed in the vagina. (b) Processing the location data from the one or more sensors to establish a performance metric; and (c) During the second treatment phase of the subject’s first therapy, continue to treat the pelvic floor muscle dysfunction, wherein the performance metric is above a predetermined threshold; or treat the subject with a second therapy different from the first therapy, wherein the performance metric is below the predetermined threshold.

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

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

65. A method for determining predetermined thresholds for performance metrics based on location data from pelvic floor muscle training therapy: (a) During pelvic floor muscle exercises during the first treatment phase of the first therapy, positional data is obtained from one or more sensors installed in the vagina. (b) After at least a portion of the first treatment phase, obtain questionnaire data from the subject including symptom severity, symptom improvement, and / or user satisfaction; and (c) Process the location data from the one or more sensors and the questionnaire data to establish a predetermined threshold for the performance metric.

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

67. The method of claim 66, wherein the questionnaire data is obtained before and after at least a portion of the first treatment phase of the first therapy.

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

69. The method of claim 62, wherein the performance metric varies with 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 includes performing a linear regression of the location data.

72. The method of claim 62, wherein the predetermined threshold varies with the subject's age, the type of pelvic floor muscle dysfunction diagnosed, and / or the severity of the pelvic floor muscle dysfunction.

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

74. The method of claim 62, wherein the performance metric comprises average lifting angle, average lifting duration, lifting frequency, 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 week 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 continues until one or more symptoms of the pelvic floor muscle dysfunction are relieved or disappear.

80. The method of claim 62, wherein processing the location data includes using an algorithm to calculate the performance metric based on the change of sensor angle over time.

81. The method of claim 62, wherein processing the location data includes using coefficients to weight the score based on: age, weight, medical history, race, exercise level, reproductive history, income level, occupation, type of pelvic floor dysfunction diagnosed, disease severity, and / or treatment adherence.

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

83. The method of claim 62, wherein the sensor is a microelectromechanical (MEM) accelerometer.

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

85. The method of claim 84, wherein a first subset of the subject population has been determined to respond to the first therapy, and a second subset of the subject population has not responded to the first therapy.

86. The method of claim 84, wherein the predetermined threshold of the performance metric comprises the minimum clinically significant difference (MCID) or patient-acceptable symptom status (PASS) of the population.

87. The method of claim 62, wherein the first treatment phase comprises alternating pelvic floor muscle lifting and pelvic floor muscle relaxation.

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

89. The method of claim 87, wherein the pelvic floor muscle lifting and the pelvic floor muscle relaxation are repeated once or multiple times.

90. The method of claim 89, wherein the pelvic floor muscle lifting and the pelvic floor muscle relaxation are repeated five times for a duration of 2.5 minutes.

91. The method of claim 87, wherein the pelvic floor muscle lifting and pelvic floor muscle relaxation 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, relative to the first treatment phase of the first therapy, performing one or more pelvic floor muscle lifts with increased frequency, duration and / or intensity.

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

95. The method of claim 62, wherein the second therapy comprises electrical stimulation therapy, anticholinergic or β-agonist therapy, use of a pessary for urinary incontinence, peripheral nerve modulation, tibial nerve modulation, sacral nerve modulation, perineal tamponade, intravaginal balloon or other prosthetic or surgical intervention.

96. The method of claim 95, wherein the surgical intervention comprises mid-urethral suspension, rectus abdominis fascia suspension, Butch vaginal suspension, or Marshall Marchetti-Krantz (MMK) vaginal suspension.

97. The method of claim 62, further comprising: (i) Obtaining position data from one or more sensors of the intravaginal device used during the one or more pelvic floor muscle lifts performed during the second therapy; and (ii) Process the location data from the one or more sensors to establish a second performance metric to determine the likelihood of success of the second therapy.

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

99. The method of claim 62, further comprising discontinuing treatment when one or more symptoms of the pelvic floor muscle dysfunction are relieved or disappear.

100. The method of claim 62, wherein the performance metric is displayed on a peripheral device, the 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 the progress of the performance metric over time.

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

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

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

105. The method of claim 62, wherein the subject's UDI-6 score after treatment is less than or equal to 37.

5.

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) Obtaining position data from one or more sensors of the vaginal device used during one or more pelvic floor muscle lifting procedures during the first treatment phase of the first therapy; and (b) Process the location data from the one or more sensors to establish a performance metric to determine the likelihood of success of the first therapy; and (c) During the second treatment phase of the subject’s first therapy, instruct the user to continue treatment for the pelvic floor muscle dysfunction, wherein the performance metric is above a predetermined threshold; Alternatively, the user may be instructed to administer a second therapy to the subject, different from the first therapy, 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 questionnaire data from the subject, including symptom severity, symptom improvement and / or user satisfaction, after 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 location data from the one or more sensors and the questionnaire data to establish the performance metric.

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

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

111. The peripheral device according to claim 110, wherein the graphical user interface is a touch screen 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 according to claim 106 and the intravaginal device comprising one or more sensors.

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

115. The system of claim 113, wherein the sensor is a MEM accelerometer.

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

117. A method for treating pelvic floor muscle dysfunction in a subject, the method comprising: (a) Obtaining positional data from one or more sensors of an intravaginal device used during one or more pelvic floor muscle lifting procedures during the first treatment phase of the first therapy; and (b) Process the location data from the one or more sensors to establish a performance metric to determine the likelihood of success of the first therapy.

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

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

120. The method of claim 117, wherein if the performance metric is above a predetermined threshold, the probability of treatment success is positive; or wherein if the performance metric is below the predetermined threshold, the probability of treatment success is negative.

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 different from the first therapy.

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