Devices, systems and methods for monitoring bladder function

Abstract

The present invention features urodynamic catheters, intravaginal and intrarectal devices, systems, and kits thereof, and methods of using the devices, systems, and kits to observe pelvic floor movements to monitor bladder function and thereby diagnose, treat, or prevent urinary incontinence disorders, such as urge incontinence and stress incontinence.

Description

Background Art

[0001] Urinary incontinence occurs in both men and women and is associated with reduced or excessive (e.g., hypertonic) pelvic floor (PF) muscle tone. Many common factors can cause reduced or increased pelvic floor muscle tone in women, such as pregnancy, vaginal delivery, pelvic surgery, aging, genetic susceptibility, neurological diseases, and weight gain. In men, urinary incontinence is usually caused by an enlarged prostate. In addition, urinary incontinence is generally divided into three types: stress urinary incontinence (SUI), urge urinary incontinence, and mixed urinary incontinence.

[0002] Current methods for diagnosing urinary incontinence include monitoring bladder function through urodynamic testing and / or voiding diaries. However, these methods generally do not provide complete information about the nature of bladder function, do not always effectively distinguish between various types of urinary incontinence, and may be affected by human error. Although urodynamic testing can be used to evaluate changes in bladder pressure and leakage caused by pressure gradients, urodynamic testing systems cannot identify or evaluate muscle movements or movements within the system caused by the Valsalva maneuver. For example, women may exhibit symptoms of excessive urethral movement, a condition associated with stress urinary incontinence, but this condition cannot be captured by urodynamic testing. In addition, contractions of the pelvic floor muscles are crucial for preventing stress urinary incontinence or suppressing urge symptoms caused by detrusor contractions, and these contractions cannot be captured by current urodynamic testing systems.

[0003] Intrinsic sphincter deficiency (ISD) is another cause of urinary incontinence. Diagnosis of ISD is typically performed by assessing urodynamic parameters (low leak point pressure or maximum urethral closure pressure (MUCP)). The absolute values of these parameters required for diagnosing ISD are uncertain.

[0004] Accordingly, there is a need for new devices, systems, and methods for monitoring bladder function in order to accurately monitor, diagnose, and treat urinary incontinence. Summary of the Invention

[0005] In a first aspect, the present invention features a urodynamic catheter including one or more position sensors. The catheter may include a plurality (e.g., 2 to 50, e.g., 2 to 20) of position sensors (e.g., MEMS accelerometers) positioned along the length of the device.

[0006] Another feature of the present invention is a system including a urodynamic catheter and an intravaginal or intrarectal device. The urodynamic catheter and / or the intravaginal and intrarectal devices may include one or more position sensors and / or other sensors. The intravaginal or intrarectal device may include a plurality (e.g., 2 to 50, e.g., 2 to 20) of position sensors (e.g., MEMS accelerometers) and / or other sensors positioned along the length of the device. The intravaginal or intrarectal device may include: a generally annular body having an outer edge configured to contact the vaginal wall, vaginal vault, or rectum; and a tether attached to the body. The length of the intravaginal or intrarectal device may be from about 2 cm to about 50 cm.

[0007] The urodynamic catheter, intravaginal device, and / or intrarectal device may include a transmitter and / or receiver (e.g., a radio frequency transmitter or receiver) for transmitting data to an electronic device. The transmitter and / or receiver may wirelessly transmit the data to the electronic device (e.g., via an electronic device supporting Bluetooth, ISM (Industrial, Scientific, and Medical) band radio, and / or Wi-Fi). The electronic device may include a display, such as a graphical user interface, such as having a touch-based user interface. The electronic device may be a computer, tablet, smartphone, or smartwatch.

[0008] In addition, the present invention features a method of evaluating a subject's bladder function by performing one or more urodynamic measurements using the urodynamic catheter or system of any of the above aspects. The one or more urodynamic measurements may include measuring one or more of position, movement, pressure, and flow. The pressure measurement may further include measuring one or more of intra-abdominal pressure, detrusor pressure, and / or intravesical pressure.

[0009] The present invention also discloses a method of keeping a diary of a subject's bladder function (e.g., filling, emptying, capacity, sensation, compliance, leakage, frequency, voiding duration, and evidence of Valsalva voiding) by using the urodynamic catheter or system of any of the above aspects or an intravaginal or intrarectal device including one or more position and / or other sensors to keep a diary. The method includes monitoring the bladder function using the urodynamic catheter, intravaginal device, and / or intrarectal device and obtaining position and / or other data from one or more position and / or other sensors of the catheter, intravaginal device, or intrarectal device. The method may further include processing the data from the one or more position and / or other sensors to determine the occurrence of bladder function and recording the occurrence of bladder function based on the processed data. The position data may include one or both of the sensor angle and time. The other sensor data may include measurements of other parameters varying over time.

[0010] The invention also features a kit that includes a urodynamic catheter as described in the above aspects and an intravaginal device or an intrarectal device that includes one or more position and / or other sensors. The kit may optionally include instructions for use. In some embodiments, the urodynamic catheter does not include any position sensors and the kit may be configured to be used as an automated voiding diary.

[0011] In some embodiments of any of the above aspects, the urodynamic catheter does not include one or more position sensors.

[0012] Definitions

[0013] As used herein, unless otherwise specified, the singular forms "a", "an", and "the" include plural references.

[0014] As used herein, the terms "about" and "approximately" mean + / - 10% of the stated value.

[0015] As used herein, the terms "adjacent" and "proximal" refer to a position close to the tissue surface (e.g., about 0.01 mm - 5 mm from the tissue surface or adjacent to the tissue surface, e.g., around the cervix or vaginal stump of a subject).

[0016] As used herein, the term "feedback" or "biofeedback" refers to information that can be used to train an individual to change physiological activities (e.g., pelvic floor muscle function) to improve health and performance (e.g., treat, reduce, and / or prevent the occurrence or symptoms of pelvic floor disorders (PFD)). Biofeedback may also include information collected by the devices of the present invention during daily monitoring, e.g., information collected substantially in real-time during the user's daily activities. This information can be viewed substantially in real-time or accessed at a later time. Instruments such as the devices of the present invention can be used to measure physiological activities such as muscle activity (e.g., movement and pressure), pressure (e.g., bladder or vaginal pressure), muscle mass, and vaginal cavity pH, temperature, and humidity, and provide this information as biofeedback to the individual. Instruments such as the devices of the present invention can also be used to measure at the molecular level, e.g., hormone levels and / or toxin levels, and provide this information as biofeedback to the individual. This information can be presented to the individual via visual, auditory, or tactile signals and can support the desired physiological changes (e.g., improve pelvic floor muscle strength, control, and mass).

[0017] As used herein, the term "calibration period" refers to the process of determining a baseline measurement set from sensors located within the devices described herein during an individual's use of the device, such that the baseline measurement set characterizes the health status (e.g., strength, muscle mass, condition) of the individual's pelvic floor muscles before or at the start of a treatment program. The baseline measurement set collected during calibration can be used to calculate and / or determine the individual's progress in a treatment plan.

[0018] As used herein, the term "diagnosis" refers to the identification or classification of a disease or disorder (e.g., a pelvic floor disorder). For example, "diagnosis" can refer to the identification of a specific type of urinary incontinence.

[0019] "Disorder" refers to any condition that can benefit from treatment, including but not limited to chronic and acute disorders or diseases, including the pathological conditions that render a subject susceptible to the disorder.

[0020] As used herein, the term "monitoring" refers to the use of the intraurethral, intrarectal, or intravaginal device of the present invention to collect, track, and / or store data, such as data obtained from the sensors of the device described herein. For example, monitoring occurs when the device is located within the vaginal cavity, rectum, or urethra of a user, and / or when the device is used during diagnosis or treatment.

[0021] As used herein, the terms "pelvic floor lift" and "PFL" refer to the movement of the pelvic floor (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 the anal sphincter) and the associated connective tissue, which spans the region in a spherical form from the anterior pubis to the posterior sacrum and reaches the adjacent bony structures connecting these two bones), characterized by an upward movement of the pelvic floor (e.g., a lifting movement, such as a movement in the cranial direction). During PFL, the movement of the pelvic floor is a well-described component of the collective movement of the entire pelvic floor (e.g., the levator ani muscle, the urethra and anal sphincter, the bulbocavernosus muscle, the ischiocavernosus muscle, the superficial transverse perineal muscle). When all the muscles are activated simultaneously, a combined lifting and circumferential squeezing effect is produced. PFL may involve selective participation of the levator ani muscle portion of the pelvic floor.

[0022] As used herein, the terms "pelvic floor relaxation" and "PFR" refer to the movement of the pelvic floor (e.g., the muscle fibers of the levator ani muscle (e.g., the pubococcygeus, iliococcygeus, coccygeus, and puborectalis muscles) and the associated connective tissue, which spans the region in a spherical form from the anterior pubis to the posterior sacrum and reaches the adjacent bony structures connecting these two bones), characterized by relaxation of the pelvic floor (e.g., a downward movement, such as a movement in the caudal direction). During PFR, the movement of the pelvic floor is different from the concentric contraction (such as a shortening contraction) of PFL, and exhibits elongation or relaxation of the muscle fibers.

[0023] As used herein, "real-time" refers to, for example, the actual time at which an event of daily activity occurs.

[0024] As used herein, "sensor data" refers to measurements (e.g., any one or more of measurements of pelvic floor muscle movement, pelvic floor muscle mass, pelvic floor muscle strength, pressure, and measurements of other conditions such as pH, temperature, and / or humidity (e.g., in the vagina)) that characterize an individual's pelvic floor health and are obtained by sensors of the intraurethral, intrarectal, or intravaginal devices of the invention as described herein. Sensor data associating pelvic floor movement with, for example, urinary incontinence or fecal incontinence or urge incontinence may also be collected. Such data can be used, for example, to diagnose urinary incontinence or fecal incontinence.

[0025] As used herein, "radio frequency" refers to electromagnetic waves having a frequency in the range of 10 3 Hz to 10 12 Hz.

[0026] As used herein, "subject", "patient", or "individual" refers to a human being.

[0027] As used herein, the terms "reduce" and "inhibit" are defined as the ability to cause an overall reduction of about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95% or more in a measurable metric. Reduction or inhibition can refer to, for example, the symptoms of a pelvic floor disorder (PFD) being treated.

[0028] As used herein, the term "treat" refers to providing treatment to a subject in need thereof (e.g., treating or reducing the likelihood of urinary incontinence or fecal incontinence, or the urgency associated therewith), particularly in combination with the use of the devices (e.g., urodynamic catheter, intravaginal device, or intrarectal device), systems, or methods described herein. "Treating a disease" or for "therapeutic treatment" includes treating a subject who already has a disease to improve or stabilize the subject's condition. "Preventing" or "reducing the likelihood of developing a disease" refers to providing prophylactic treatment to a subject who has not yet developed the disease or is asymptomatic but is predisposed or at risk of developing a particular disease such as urinary incontinence or fecal incontinence.

[0029] As used herein, "female urogenital system" refers to the organ system of the female reproductive system, which includes, for example, Bartholin's glands, cervix, clitoris, clitoral frenulum, clitoral glans / glans clitoridis, clitoral hood, fallopian tubes, labia, labia majora, labia minora, labia minora frenulum, ovaries, sebaceous glands, uterus, vagina, and vulva; the urinary system, including, for example, the kidneys, ureters, bladder, and urethra; and the surrounding and supporting nerve and muscle tissues.

[0030] As used herein, "male urogenital system" refers to the organ system of the male reproductive system, which includes, for example, the bladder, pubis, external urethral sphincter, penis, penile shaft, corpora cavernosa, glans penis, foreskin, urethral orifice, sigmoid colon, rectum, seminal vesicles, ejaculatory ducts, prostate, Cowper's glands, anus, vas deferens, epididymis, testicles, and scrotum; and the surrounding and supporting nerve and muscle tissues.

[0031] As used herein, "vaginal stump" refers to the sutured tissue remaining at the top of the vaginal cavity after excision of the cervix (e.g., during a hysterectomy).

[0032] As used herein, "urinary incontinence" refers to the leakage of urine from the bladder. The incontinence can range from just a few drops of urine leakage to complete emptying of the bladder. Urinary incontinence can be divided into three main types: stress urinary incontinence (SUI), urge urinary incontinence, and mixed urinary incontinence. Stress urinary incontinence refers to urine leakage during coughing, laughing, or sneezing. Women may also experience leakage while walking, running, or exercising. Urge urinary incontinence is a sudden and intense urge to urinate that is difficult to stop. Women with this type of urinary incontinence may leak urine on the way to the bathroom. Mixed urinary incontinence combines the symptoms of stress and urge urinary incontinence.

[0033] As used herein, "pelvic floor" refers to the muscular area at the bottom of the abdomen attached to the pelvis.

[0034] As used herein, "pelvic floor disorder" or "PFD" refers to diseases that affect the muscles and tissues supporting the pelvic organs. These diseases may cause loss of control of the bladder or bowel, or may cause one or more pelvic organs to sag downward, resulting in prolapse.

[0035] As used herein, "urodynamic catheter" refers to a urethral catheter configured to perform one or more urodynamic measurements. The catheter may have multiple (e.g., 2 or 3) lumens. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The application file contains at least one drawing executed in color. Copies of this patent or of the patent application with color drawings will be provided by the Patent Office upon request and payment of the necessary fees.

[0037] FIG. 1 is a schematic diagram of a dual-lumen urodynamic catheter having a plurality of position sensors (e.g., MEMs accelerometers) 200 positioned along the length of the device.

[0038] FIG. 2 is a graph plotting urodynamic measurements. The vertical axis of the graph shows flow rate, electromyogram, detrusor pressure, bladder pressure, abdominal pressure, and volume, and the horizontal axis shows time.

[0039] Figure 3 is a schematic view showing the intravaginal device 100, which has a body 110 (which may have, for example, an annular body or an incomplete annular body), a tether 10, and a transmitter / receiver box 500. The tether 10 may be non-detachable from the body 110, or, if detachable from the body 110, the tether is configured to be easily removable. The intravaginal device 100 includes a circuit board 700 in the body 110 or the tether 10, which is connected to a sensor 200 (e.g., an accelerometer (e.g., a MEMS sensor)), a battery 800, a microcontroller 900, an internal transmitter / receiver 1000, a data storage component 1100, a sensory output component 1200, a wireless communication antenna 1300, an authentication chip 1400 (e.g., an Apple product authentication chip), and an ON / OFF switch 1600. The intravaginal device 100 may also include molded wings 300 for reducing rotation and sliding of the device within the vaginal cavity of an individual. The intravaginal device 100 may also include an energy transmitter 210 (shown as a hatched box) on the body 110 or the ring 10. Any of the above components may or may not be present on the intravaginal device 100, such components, for example, the energy transmitter 210 (e.g., an RF transmitter is optional).

[0040] Figure 4 is a schematic view showing the intravaginal device 100 having a body 110 and a tether 10. The shown body 110 includes five sensors 200 (e.g., accelerometers, e.g., MEMS sensors), and the shown tether 10 includes eight sensors 200. One sensor 200 is shared by the body 110 and the tether 10.

[0041] Figures 5A-5D are schematic views showing the vaginal angle (θ V ) and the fornix angle (θ F ) with reference to the intravaginal device 100 (e.g., when inserted into the vaginal cavity of a subject). When placed in the vaginal cavity of a subject, the sensor pair 1 of the intravaginal device 100 shown in Figure 5A is located in the anterior fornix, and each sensor of the sensor pair 2 is located in the lateral fornix. The remaining single sensor, i.e., sensor 3, is located in the posterior fornix, and this last one is also part of the tether. Figure 5B The anterior fornix sensors labeled A9 and A12, the sensors in the lateral fornix labeled A10 and A11, and the single posterior fornix sensor labeled A8 shared by the body 110 and the tether 10 are shown. The sensors proprietary to the tether 10 are labeled A1-A7. The vaginal angle (θ V) The angle between the line defined as the tether (substantially the dividing line of the longitudinal axis of the vagina) and the line contained in a plane parallel to the virtual plane of the vaginal entrance, hereinafter referred to as the "horizon". The fornix angle (θ F ) is defined as the angle between the line connecting the anterior and posterior fornices (the anterior and posterior points of the body) and the horizon. Figure 5C It is shown that (1) each sensor of the tether can be connected by a best-fit line, and (2) the positions of the sensors in the two anterior fornices can be averaged; similarly, the positions of the sensors in the lateral fornices can also be averaged, and a best-fit line is drawn from the posterior fornix to the anterior fornix. The vaginal angle (θ V ) and the fornix angle (θ F ) are shown in Figure 5C and 5D. In Figure 5D, the points ("nodes") shown in Figure 5C are labeled S1 - S10. The sensors drawn are, for example, accelerometers, such as MEMS sensors.

[0042] Figure 6 is a graph, with the ordinate being the sensor angles (degrees) of sensors S1 - S8 of the intravaginal device in Figures 4 and 5, and the abscissa being the time (seconds) when the subject performs a series of actions indicated by vertical lines (pelvic floor relaxation, Valsalva maneuver, pelvic floor elevation, sustained pelvic floor elevation (hold), and continuous repeated pelvic floor elevation (repeat)). Sensor 5 shows the largest change in sensor angle during the above actions. The sensor data is generated using MEMS sensors.

[0043] Figures 7A - 7B are a set of graphs, with the ordinate being the combined sensor angle scores (Y1 and Y2) obtained using the intravaginal device in Figures 4 and 5, and the abscissa being the time (seconds) when the subject performs a series of actions indicated by vertical lines (pelvic floor relaxation, Valsalva maneuver, pelvic floor elevation, sustained pelvic floor elevation (hold), and continuous repeated pelvic floor elevation (repeat)). Figure 7A shows the sensor angle plotted as a function of time, and Figure 7B shows the first derivative of time with respect to the data in Figure 7A, which shows the change in the sensor angle as a function of time.

[0044] Figure 8 shows the use in 10 different subjects Figure 4The sensor angle change value for each sensor obtained with the intravaginal device of 5. Each bar graph represents the sensor angle (angle during elevation - angle during relaxation) of each of the sensors S1 - S10 used by each subject. The horizontal line represents the average sensor angle for a given sensor. S4 - S6 provided the largest and most consistent signal - to - noise ratio, amplitude, and directivity. The sensors provided the strongest signal, and the vaginal length for each subject was indicated. For three subjects, the "trained" label reflected that the subjects showed markers indicating the absence of pelvic floor disorders.

[0045] Figure 9 is a magnetic resonance imaging (MRI) scan image of the levator ani muscle group and the external anal sphincter muscle group in the pelvic floor. The pubovaginalis muscle (PVM) (e.g., pubococcygeus muscle (PCM)), iliococcygeus muscle (ICM), puborectalis muscle (PRM), and external anal sphincter (EAS) are shown and labeled in the scan. The sacrococcygeal inferior public point (SCIPP) line is drawn on the midsagittal plane and transposed to all parasagittal plane slides. The orientation (angle) of the muscle fibers is represented by the line drawn on top of the muscle group and is measured relative to the horizontal line. The fiber direction is labeled and evaluated according to a single SCIPP line and is represented as the angle with the average horizontal line, i.e., 34º below the SCIPP line. The fiber orientation with a clockwise - oriented angle with respect to the horizontal line is assigned a negative sign, while the fiber orientation with a counterclockwise - oriented angle with respect to the horizontal line is assigned a positive sign. The intravaginal device has a ring, a tether, and multiple accelerometers spaced along the length of the device and is overlaid on the MRI scan.

[0046] Figure 10 is a schematic diagram showing the levator ani muscle group and the external anal sphincter muscle group in the pelvic floor. The thick arrow shows the average direction of the horizontal line in the two - dimensional figure. The dashed line is the horizontal line for measuring the angle. The angle above the horizontal line is assigned a positive sign, and the angle below the horizontal line is assigned a negative sign. MRI shows that the PVM is located medial to the PRM. The intravaginal device, which has a ring, a tether, and multiple accelerometers spaced along the length of the device, is overlaid on the image.

[0047] Figure 11 is a schematic diagram showing the levator ani muscle group and the external anal sphincter muscle group in the pelvic floor. The thick arrow represents the average direction of the movement line of the PVM and PRM muscles relative to the horizontal direction, with a theoretical force of 1 N. The thin lines represent the parts of each force related to the closing and elevation functions. The intravaginal device, which has a ring, a tether, and multiple accelerometers spaced along the length of the device, is overlaid on the image. Detailed Description

[0048] The present invention features devices, systems, and methods for diagnosing urinary incontinence and monitoring bladder function in a subject (e.g., a male or female subject) by using alone a urodynamic catheter comprising one or more position sensors or in combination with an intra-vaginal or intra-rectal device comprising one or more position sensors.

[0049] During urodynamic testing, the urodynamic catheter may use one or more sensors (e.g., accelerometers) to monitor the subject's pelvic floor movement for more accurate monitoring of bladder function. Additionally, the device and system may be used to create an automated or digital bladder diary that provides more reliable quantitative data regarding bladder function. The system may also include a peripheral device that includes a computer processing unit configured to collect data from sensors on the urodynamic catheter or the intra-vaginal or intra-rectal device and convert the data into useful physiological markers representative of the subject's diagnostic or treatment status. The data may then be presented to the subject or another individual (such as a healthcare provider) to provide feedback or an alert regarding the physiological markers. The peripheral device may be configured with one or more algorithms for analyzing position data from sensors of the device or system. The devices and systems described herein may be configured to provide monitoring of the overall health status of the subject's urogenital system and pelvic floor (e.g., the muscle fibers of the levator ani muscle, e.g., the pubococcygeus, iliococcygeus, coccygeus, puborectalis muscles, and associated connective tissues) substantially in real-time, e.g., when the subject is undergoing urodynamic testing or when the subject is performing daily activities. The device and system may be configured to evaluate the subject's pelvic floor movement to identify movements associated with urodynamic measurements. The device and method may use information from the device for accurate diagnosis of urinary incontinence (e.g., stress urinary incontinence, urge urinary incontinence, or mixed urinary incontinence) and may determine a course of treatment suitable for the subject so that the subject can achieve treatment goals such as reducing urinary incontinence, the occurrence and / or severity of urinary incontinence.

[0050] The devices and systems described herein may also be used alone or in combination with a peripheral device configured to receive sensor data from the urodynamic catheter or the intra-vaginal or intra-rectal device to monitor (e.g., using one or more sensors described herein) the overall urodynamic status of the subject's urogenital system and pelvic floor when a clinician is performing urodynamic testing or when the subject is performing their daily activities. The peripheral device may be configured with a processing unit that may transform or utilize sensor data received from the catheter, intra-rectal, and / or intra-vaginal device during urodynamic testing or during a urinary / voiding episode to provide feedback to the subject (or healthcare provider) to determine an appropriate diagnosis and / or treatment course.

[0051] Urodynamic catheter

[0052] As described herein, the present invention features a urodynamic catheter having an elongate body and one or more position sensors (e.g., MEMS accelerometers) positioned along its length. The urodynamic catheter can be used alone or as part of a system to monitor pelvic floor movement, such as during, before, or after urodynamic testing, or to generate a voiding diary. The urodynamic catheter is configured to be inserted into the urethra of a subject (e.g., a male or female subject) such that one or more position sensors provide spatially oriented position readings of the subject's urethra. The readings provided by the urethral position can serve as a surrogate for the spatial arrangement of the pelvic floor and pelvic organs including the urethra. For male subjects, the orientation of the urodynamic catheter can provide information about the prostate position. The urodynamic catheter can also include one or more additional sensors, such as motion, pressure, and / or flow sensors. The urodynamic catheter can be structurally configured in any suitable geometry to fit the urethra of the subject. The urodynamic catheter can have multiple, e.g., two lumens. One lumen can be used to fill the bladder and one lumen can be used to measure pressure ( Figure 1 ).

[0053] For example, exemplary urodynamic catheters that can be modified to produce the urodynamic catheter described herein are described in U.S. Patent Nos. 6,447,462, US 5,984,879, and U.S. Publication Nos. US20060122488, US20030097039, US20060276712, US20060281992, and US20170258345, the disclosures of which are hereby incorporated by reference in their entireties.

[0054] The urodynamic catheter can include at least one thin-walled, circumferentially extending balloon near its distal or subject end that transmits external pressure located proximal to the balloon to a transducer located outside the subject through a small-volume, closed air column. During multichannel bladder pressure measurement, the catheter can be inserted with at least one balloon in a constricted state, and the balloon inflates after the catheter enters the subject's bladder, vagina, or rectum.

[0055] The urodynamic catheter includes at least one pressure lumen that extends from the proximal end to the distal end of the outer tube and has a discharge hole that terminates within a range of a small-diameter balloon that circumferentially surrounds the outer tube at or near the distal end of the outer tube. After insertion into a subject, the proximal end of the pressure lumen can be connected to a housing equipped with a transducer through a disposable connector, and then an air column extending between the balloon and the transducer can be sealed and filled with a small volume (e.g., 1 - 100 µL, such as 5 µL, 10 µL, 15 µL, 20 µL, 25 µL, 30 µL, 40 µL, 50 µL, 60 µL, 70 µL, 80 µL, 90 µL, or 100 µL) of fluid (e.g., air or water). The inflation can be achieved by replacing the air volume within the air column to minimize the dead zone therein after sealing the air column. In one embodiment of the present invention, two independently inflatable balloons can be used, one near the distal end of the catheter and the other at a distance from the distal end of the catheter (e.g., 1 - 100 cm, such as 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 20 cm, 30 cm, 40 cm, 50 cm, 60 cm, 70 cm, 80 cm, 90 cm, 100 cm).

[0056] The balloon of the urodynamic catheter may have a relatively small diameter when fully inflated (e.g., 0.01 - 0.5 inches, such as 0.02 inches, 0.03 inches, 0.04 inches, 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.1 inches, 0.2 inches, 0.3 inches, 0.4 inches, 0.5 inches, such as 0.160 inches), and a relatively small length at the moment of inflation (e.g., 0.01–0.5 inches, such as 0.02 inches, 0.03 inches, 0.04 inches, 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.1 inches, 0.2 inches, 0.3 inches, 0.4 inches or 0.5 inches) to enhance the coupling of urethral pressure. The wall of the balloon may be very thin (e.g., 0.0002 - 0.0010 inches, such as 0.0004 inches, 0.0006 inches, 0.0008 inches or 0.0010 inches), thus generating flexibility so that the folds do not generate excessive force or pressure that may interfere with the measurement. This provides an ideal fluid pressure transmission through the balloon membrane. In addition, the balloon volume can be thermally stabilized by using heat-shrinkable materials so that the balloon shrinks to a fixed volume, and a hot air stream is used to attach to the outer tube through the heat-shrunk balloon end ends, thus avoiding the need for a separate heat-shrinkable tube clamp or adhesive at the balloon end and providing an extremely smooth transition between the outer tube and the balloon outside the catheter. A small inner diameter (e.g., about 0.005 - 0.008 inches) pressure lumen about 18 - 24 (e.g., 19, 20, 21, 22, 23 or 24) inches long leads to the balloon, providing a relatively small internal volume relative to the balloon volume within the closed air column, thus ensuring an acceptable frequency response and providing a relatively wide measurement range (e.g., between 0 and 250 cm H 2 O).

[0057] The size of the catheter can be determined according to the French catheter scale, where the outer diameter of each gauge is 1 / 3 mm. The outer diameter of a size 7 French catheter is 2.333 mm, and its structure provides flexibility for easy insertion and increases the comfort and safety of the subject. The use of a pressure lumen with a different, higher hardness compared to the outer tube provides a soft outer sheath and a rounded distal end of the catheter, which are combined with a more rigid and less kink-prone pressure lumen within the outer tube to achieve an accurate, small-diameter pressure line. The pressure line has a lower risk of perforation due to its rigidity and is less prone to being positioned in place when curled in a packaging bag during transportation and storage prior to use. In addition, the pressure lumen is not attached to the outer tube except at the balloon location at the distal end of the pressure lumen and at the location where the pressure lumen exits the outer tube, thus facilitating a flexible catheter with a lower risk of kinking and minimizing the contribution of the pressure lumen to the overall catheter stiffness. Similarly, the fill tube extending from the proximal end of the outer tube to near the port at its distal end is fixed to the outer tube only near the attachment of the pressure lumen and more distally at the point where the pressure lumen exits the outer tube.

[0058] The urodynamic catheter includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) sensors configured to detect muscle movements, such as PFL and / or PFR. In some cases, the sensors can be configured to detect muscle movements, such as PFL and / or PFR, substantially in real time. In some cases, one or more sensors can be selected from the group consisting of: motion sensors, orientation sensors, accelerometers, gyroscopes, micro-electro-mechanical system (MEMS) sensors (e.g., MEMS accelerometers), gravity sensors, tilt sensors, rotation sensors, pressure sensors, temperature sensors, humidity sensors, electromyography (EMG) sensors, light detection sensors (such as LiDAR sensors), EIM sensors, and combinations thereof.

[0059] Two or more sensors as described herein may be placed around the longitudinal axis of the catheter, such as in a circular or helical pattern around the central axis of the catheter body and / or tether, at approximately ±1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, or 270° relative to each other. Alternatively or additionally, two or more sensors as described herein may be placed such that they are spaced apart along the catheter by about 0.001 mm, 0.01 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 225 mm, 250 mm, 275 mm, 300 mm, 325 mm, 350 mm, or further. In some cases, two or more sensors as described herein may be placed along the central axis of the catheter. In some cases, two or more sensors as described herein may be placed such that they are not on the central axis, for example such that they are offset from the central axis of the catheter. The sensors may be positioned on the surface of the catheter such that all or a portion of the sensors are in direct contact with urethral tissue. In some cases, the sensors may be positioned about 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or further below the outer surface of the catheter (e.g., the surface in direct contact with urethral tissue). In some cases, the sensors may be positioned such that about 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or more of the sensor protrudes from the outer surface of the catheter. Alternatively, the sensors may be positioned within the catheter such that the sensors do not directly contact the urethra, but are positioned to detect movement during pelvic floor motion.Sensors can be positioned uniformly or non-uniformly at intervals along or within the catheter. The sensors within the catheter can be positioned such that when the catheter is inserted into a subject, the sensors face the abdominal direction (e.g., the anterior direction).

[0060] The catheter may further include a transmitter and / or a receiver for communicating wirelessly or via a detachable cable with an electronic device (e.g., a peripheral device such as a handheld or portable device or a computer such as a smartphone, a tablet, or a laptop). Alternatively, the transmitter and receiver may be located in a housing and connected to the catheter wirelessly or via a detachable cable. The transmitter and receiver can be directly or indirectly connected to a microcontroller, sensors, and / or a circuit board. The transmitter and receiver can be configured to be used with electronic devices that support Bluetooth, ISM, Wi-Fi, and / or RF. Information collected by the sensors can be wirelessly transmitted (e.g., downloaded, transferred) to the electronic device by the transmitter and / or receiver and / or by using a detachable cable. The electronic device can include a user interface. The user interface can be programmed to display data and / or provide instructions for using the catheter. The catheter further includes 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.

[0061] Urodynamic evaluation method

[0062] Urodynamic evaluation can be used to identify the type and magnitude of incontinence experienced by a subject. This evaluation can be performed in combination with other physiological markers obtained from the subject, such as from a physical examination or from an open or recorded medical history. Urodynamic evaluation can be performed using the devices, systems, and kits described herein. Exemplary urodynamic tests are uroflowmetry, post-void residual measurement, intravesical pressure measurement tests, leak point pressure measurement, pressure-flow studies, electromyography, and videourodynamic tests. Urodynamic tests can include measuring bladder pressure to, for example, compare with a reference abdominal pressure obtained through a rectal or vaginal probe; and measuring urethral pressure to compare with bladder pressure. Stress urinary incontinence (SUI) can be diagnosed during bladder filling, as can detrusor incontinence (DI). SUI is notable for its response to laughter, coughing, or other irritating effects with urination, while DI is associated with involuntary, apparent, periodic detrusor contractions that trigger urination. Overactivity and ISD can be identified by using two different conventional diagnostic methods: urethral pressure profile (UPP) and Valsalva leak point pressure study (VLPP study). UPP measures urethral pressure versus bladder pressure as a catheter is withdrawn from the bladder through the urethra. The VLPP study fills the bladder to one or more selected volumes at which the subject slowly bears down as if to urinate to a point at which leakage through the catheter occurs or a selected bladder pressure differential above baseline pressure is reached.

[0063] Urodynamic evaluation is used to obtain quantitative data regarding the bladder. A bladder filling study, also known as filling cystometry, measures the relationship of bladder pressure to the volume of fluid contained. Bladder capacity and compliance (the ability of the bladder to accommodate increasing volumes) are measured, as well as the urge to void from a subjective, urgent perspective. Finally, the detrusor stability even under the types of provocation described above, or the ability of this muscle group to remain relaxed during bladder filling, is quantified.

[0064] Multichannel cystometry can be employed to correct the measured bladder pressure to obtain the true bladder pressure by subtracting the abdominal pressure. Bladder pressure can be measured by a sensing element or port at the distal end of a catheter inserted transurethrally into the bladder, while abdominal pressure is measured by a sensing element at the distal end of a catheter inserted into the subject's rectum or vagina. The difference between the two readings, quantified in cm H 2 O units, is characterized as the detrusor pressure. Monitoring the relationship between the observed bladder pressure and abdominal pressure during bladder filling, including the response to provocation, results in a cystometrogram that records quantitative bladder function.

[0065] Multichannel urodynamic testing assesses bladder function during both the filling and voiding phases. The test is typically performed by inserting a pressure-sensing catheter into the subject's bladder / urethra (two sensors along the length of the catheter, one intended for the urethra and the other in the bladder) and into the vagina or rectum (for an abdominal pressure surrogate). Additionally, surface electromyography (sEMG) pads (or periurethral electrodes) can be added to evaluate periurethral muscle activity. The bladder is then filled via the catheter, and bladder volume, sensation, and compliance are noted. Once full, a provocative maneuver is performed to determine leakage due to stress urinary incontinence (leak point pressure) or to evaluate the closure pressure of the urethra (MUCP). Pressure tracing (e.g., time-versus-pressure) can be used to identify detrusor (bladder muscle) overactivity, which may be consistent with urge incontinence or neurogenic bladder. Additionally, voiding (bladder emptying) is evaluated to observe the pressure required to empty the bladder, the nature of the urine stream (e.g., intermittent or continuous), and the velocity of the urine stream. These evaluations can be used together to diagnose conditions such as detrusor overactivity, neurogenic bladder, stress urinary incontinence, intrinsic sphincter deficiency, sphincter dyssynergia, urinary retention, decreased / increased compliance, and inadequate detrusor contraction.

[0066] A position sensor (e.g., an accelerometer) within the urodynamic catheter (e.g., in the urethral portion) allows detection of urethral movement during bladder filling, voiding, and Valsalva. This can provide a simultaneous and accurate diagnosis of urethral hypermobility by precisely measuring the angular changes of the urethra during bladder filling, voiding, and Valsalva. Using pattern recognition, angular changes related to bladder filling and voiding, as well as those related to Valsalva, can be identified in order to provide an accurate diagnosis of stress urinary incontinence by quantifying the angular changes during these events and correlating the angular change markers with those occurring in subjects with urethral hypermobility or ISD, thus diagnosing these conditions in the subject.

[0067] A position sensor (e.g., an accelerometer) within a urodynamic catheter can also be used to identify pelvic floor movements in response to detrusor contractions or Valsalva. Visualizing these patterns can confirm the presence of urge inhibition by pelvic floor muscle contractions. Current urodynamic tests cannot detect whether a subject with urge incontinence experiences urge inhibition using pelvic floor muscle contractions. As described herein, adding a position sensor to a urodynamic catheter reveals a more comprehensive understanding of the source of urge incontinence (detrusor overactivity versus inactive or underactive urge inhibition). This additional understanding can be used to guide treatment decisions, such as recommending pharmacologic therapy for detrusor overactivity or physical therapy for inactive or underactive pelvic floor muscles.

[0068] Understanding the muscle contractions associated with Valsalva can help clarify the nature and effectiveness of pelvic floor muscle contractions to stop urine leakage due to increased intra-abdominal pressure.

[0069] The "trick" is an early pelvic floor squeeze that prevents stress urinary incontinence. Understanding the timing of a subject's trick can reveal the impact of pelvic floor muscle activity during urine leakage and how pelvic floor muscle training can help reduce or eliminate urine leakage caused by SUI.

[0070] Pelvic floor disorders

[0071] The devices, systems, and kits of the present invention can be used to monitor and diagnose pelvic floor disorders. Pelvic floor disorders include urinary tract disorders, which are disorders that cause difficulty with bladder storage; or incontinence, including the body's inability to control the excretion of urine. The types and prevalence of urinary incontinence in ambulatory adult women include stress urinary incontinence (SUI), detrusor instability (urge incontinence), mixed incontinence (stress and urge), and other urinary incontinence (overflow, neurogenic). It has been observed that the prevalence of detrusor instability and mixed incontinence increases with the age of the subject sample. Male subjects may experience similar urinary incontinence problems, which are typically associated with prostate enlargement. Males also have problems with urinary retention due to the prostate.

[0072] SUI can be characterized as involuntary urination that occurs when the intravesical pressure exceeds the maximum urethral pressure in the absence of detrusor contractions. Stress urinary incontinence may include accidental urination due to laughing, sneezing, coughing, or standing because any such exertion causes increased abdominal pressure, which when transmitted to the bladder and the urine contained therein exceeds the flow resistance generated by the urethra, primarily the urethral sphincter. SI can be further classified as excessive bladder neck mobility and intrinsic sphincteric deficiency (ISD).

[0073] Overactivity of the bladder neck may be caused by pelvic floor descent and may be attributable to weakened pelvic floor muscles and connective tissue. This may be observed in combination with genital nerve injury caused by childbirth, but may also occur in young nulliparous women. In the normal position, the bladder is supported by pelvic muscles, which prevents an increase in abdominal pressure from exceeding urethral pressure. When the pelvic muscles are weakened or damaged, the bladder neck abnormally displaces during abdominal pressure, and the urethral sphincter closing pressure becomes insufficient to maintain continence. Micturition due to SI related to overactivity typically occurs in a cyclic manner, and the volume of urine may be proportional to the severity of the condition.

[0074] ISD is the severe form of stress urinary incontinence, which may occur due to an inherent defect in the urethral closing mechanism or due to a dysfunctional urethra in which the bladder neck is open at rest. Severe ISD results in continuous urine leakage or urine leakage in response to minimal effort by the subject. In ISD, the bladder neck may be fixed or hypermobile. ISD occurs in a significant number of cases due to urethral scarring resulting from past incontinence surgery, but may also be caused by other reasons. Only a small number of subjects exhibit stress urinary incontinence attributable to ISD.

[0075] Diagnostic methods

[0076] Depending on the particular urological disorder, urodynamic catheters can be used to identify and / or diagnose a particular disorder during urodynamic testing. Subjects with overactive bladder may exhibit a reduced overall range of motion (e.g., a limited range of angular change), with frequent small elevations in sensors S4 - S6. The movement patterns in the proximal sensors (e.g., S9 and S10) can correspond to urge episodes with or without urinary incontinence. Subjects with urge incontinence may exhibit a reduced overall range of motion (e.g., a limited overall angular change range), where the pattern indicates frequent small voids (e.g., frequent brief relaxation patterns). The movement patterns in the proximal sensors (e.g., S9 and S10) can correspond to urge episodes with or without urinary incontinence. Subjects with fecal incontinence may exhibit a reduced overall range of motion (e.g., a limited range of angular change), where the angular change increases frequently and prolongedly (indicating an attempt to hold feces and / or control defecation). Alternatively, subjects with fecal incontinence may exhibit an increased overall range of motion, which may be particularly evident on the posterior vaginal wall during depression, but with a corresponding reduced horizontal movement during voluntary pelvic floor muscle contractions. Compared to population means, subjects with constipation may exhibit a limited overall range of motion (e.g., a limited range of angular change) and signs of a prolonged Valsalva (e.g., a small reduction in angular change). By identifying the angular change patterns associated with each particular disorder, one (e.g., a clinician) can diagnose a subject as having a particular disorder and select an appropriate therapy for the subject.

[0077] Some subjects will undergo an initial test phase to detect patterns of angular change (e.g., from specific sensors, such as associated with specific activities) in conjunction with urodynamic testing. These patterns and angular changes can be compared to those observed prior to diagnosis or treatment to determine any changes associated with them.

[0078] The trends and patterns of angular change of sensors (e.g., MEMS accelerometers) observed during urodynamic testing can be predicted based on the positions, movements, and relative orientations of various levator ani and anal sphincter muscle groups, as discussed below (see also, for example, Figure 9 to 11). The orientations of these muscle groups are described in, for example, Betschart et al.( Int. Urogynecol.J. 25: 1263 - 1268, 2014), the disclosure of which is hereby incorporated by reference in its entirety.

[0079] Methods for detecting pelvic floor movement

[0080] The position sensors of the urodynamic catheter can be used to track pelvic floor movements (e.g., pelvic floor lift, pelvic floor relaxation, Valsalva maneuver, sustained pelvic floor lift, and continuous repeated pelvic floor lift). The trends and patterns of the angular changes of the sensors (e.g., MEMS accelerometers) observed during urodynamic testing or urination can be predicted based on the positions, movements, and relative orientations of various levator ani and anal sphincter muscle groups ( Figure 9 to 11). For example, in an intravaginal device, sensors S4 - S6 ( Figure 5B ) provide consistent signal - to - noise ratio, amplitude, and directionality ( Figure 8 ). Sensor S6 also provides a strong signal - to - noise ratio, but the directionality may vary among different subjects. Although this data was generated using an intravaginal device, the same type of data can also be generated by the urodynamic catheter described herein. One can use the data generated from one or more of these sensors in an algorithm that uses the sensor data to track angular changes during daily activities in order to monitor different pelvic floor movements. The sensor data can be processed and displayed to the subject or others through a graphical user interface. For example, text messages, emails, alerts can be sent to the subject or another individual via an application running on the subject's peripheral device (e.g., smartphone). The microcontroller can store the computed data, for example, using a non - transitory storage medium. An algorithm can be used that defines one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) parameters that constitute a composite score of one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) sensor angle measurements. During a treatment or monitoring session (e.g., during pelvic floor movement), an algorithm can be used to track the angular changes of a single sensor or multiple sensors. The first - order time derivative of the angle versus time can be used to indicate the positive or negative change of the angle with respect to time. A positive angular change can indicate the start time or amplitude of a pelvic floor movement (e.g., lift), while a negative angular change can indicate the end time or amplitude of the decline (e.g., relaxation) of a pelvic floor movement. A second - order time derivative can be generated and used to indicate local maxima or minima that indicate when the movement starts or ends (e.g., the rate of change of the angle with respect to time is zero). Additionally, the algorithm can be used to detect any pelvic floor movement that indicates the presence of a pelvic floor disorder or its symptoms.

[0081] Each MEMS accelerometer emits a signal corresponding to its position relative to the horizon and the sensor angle. The angular data from each sensor can be plotted as a function of time (see, for example Figure 6, which shows MEMS sensor data generated using the intravaginal device as described herein). Then, a composite score can be calculated from the sum of one or more of the sensor angles. The algorithm can include, for example, calculating a moving average or a filtered composite score to reduce noise and minimize false positives. The filtered composite score can be plotted relative to time (see, for example Figure 7A , which shows MEMS sensor data generated using the intravaginal device as described herein), and the derivative of this data can be plotted as the change in sensor angle relative to time (see, for example Figure 7B , which shows MEMS sensor data generated using the intravaginal device as described herein). When the change in sensor angle relative to time exceeds a predetermined threshold (e.g., 1º, 2º, 3º, 4º, 5º, 10º, 15º, 20º, 25º, 30º, 35º, 40º, 45º, e.g., about 18°), a pelvic floor movement can be determined. The predetermined threshold can be determined empirically based on data collected from different subjects. The start of a pelvic floor lift can be determined at or around the moment when the time derivative of the composite score of the filtered composite score exceeds the predetermined threshold. The peak of the moving average (e.g., Y_max) can indicate the magnitude of the pelvic floor movement (e.g., lift). The change in the composite score from the start to the end of the movement can be defined as Δ. When the composite score of the filtered average drops below the difference between the maximum score and half the maximum value of Δ (e.g., Y drops below Y_max - 0.5 × ΔY), it can be determined that the pelvic floor movement has ended. The coefficient before Δ can be determined empirically and can vary, for example, from 0.1 to 1.0 (e.g., 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1.0). The start and end times of the movement can also be identified when the second derivative of the sensor angle relative to time reaches zero (see, for example Figure 7B ). Then any data or markers generated by the urodynamic catheter can be presented to the subject. Additionally, these markers can be used to diagnose the subject and can be used to indicate an appropriate course of therapy.

[0082] Intravaginal device

[0083] An intravaginal device having a body and / or a tether as described herein can be used as part of a system for monitoring pelvic floor movement during, before, or after urodynamic testing. Alternatively, the intravaginal device can be used alone or in combination with a urodynamic catheter and / or a rectal device to generate a voiding diary. The device can be inserted into the vagina of a female subject such that the intravaginal device is proximal to the cervix or vaginal stump. The intravaginal device includes one or more position sensors (e.g., MEMS accelerometers) and / or other sensors. The position sensors and / or other sensors provide sensitive position information and / or other information that can be used to sensitively monitor pelvic floor movement and / or assess the pelvic floor architecture or other health aspects of the subject.

[0084] Specifically, the intravaginal device can be used in combination with a urodynamic catheter during urodynamic testing to detect patterns of angular change. For example, specific sensors in the intravaginal device can be monitored during urodynamic testing to assess patterns and angular changes in the pelvic floor as an alternative to assessing pelvic floor muscle physiology. To accurately diagnose pelvic floor disorders in the tested subject, the patterns and angular changes can be compared to those observed prior to diagnosing or treating the tested subject or a subject with a known pelvic floor disorder (e.g., urinary incontinence).

[0085] Trends and patterns of angular change of sensors (e.g., MEMS accelerometers) observed in a urodynamic catheter and an intravaginal device during urodynamic testing can be used to diagnose or predict a disease state based on the position, movement, and relative orientation of pelvic floor muscles (e.g., various levator ani and anal sphincter muscle groups) and / or pelvic floor organs, or to assess the efficacy of a selected therapy in a subject.

[0086] Exemplary intravaginal devices, systems, and methods for training, visualizing, and diagnosing the health status of a subject's pelvic floor muscles are described in detail in PCT Application No. PCT / US2018 / 057811, International Publication No. WO2018023037, and U.S. Application Nos. 62 / 577,811, 62 / 625,301, and 62 / 657,585, the disclosures of which are hereby incorporated by reference herein.

[0087] The intravaginal device has a body with an outer edge configured to contact all or a portion of the vaginal wall surrounding the cervix or vaginal stump, and the internal diameter of the intravaginal device is sized to circumferentially surround the cervix or vaginal stump generally. The internal diameter and the external diameter of the intravaginal device may be substantially equal, and the difference in their lengths is attributable to the thickness of the material used to manufacture the intravaginal device. The length of the internal diameter and / or the external diameter may be from about 20 mm to about 80 mm (e.g., about 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, or 80 mm). In some cases, the internal diameter of the intravaginal device may be less than the external diameter. In some cases, the intravaginal device may be manufactured with a tether (e.g., a flexible cord or strap) that may optionally be attached to the body of the intravaginal device, for example, by a removable or permanent connection, and the tether may have a length of up to about 14 cm (e.g., 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, or 14 cm) and a width of from about 1 mm to about 10 mm (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm). Different form factors of the device include rings (circular or oval), rings with tethers, and incomplete rings (e.g., horseshoe configurations).

[0088] The outer edge of the body of the intravaginal device may be configured to apply pressure, tension, adhesion, and / or suction to the vaginal wall to maintain the position of the intravaginal device in a position adjacent to the cervix or vaginal stump of the individual. The pressure, tension, adhesion, and / or suction applied to the vaginal wall by the outer edge of the intravaginal device has sufficient force to limit slippage, repositioning, or displacement of the intravaginal device from the vaginal cavity of the individual.

[0089] In addition, the body of the intravaginal device can include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more) features for stabilizing, orienting, and / or positioning the device within the body of an individual. The features can be selected from the group consisting of: coatings, protrusions, and textures. In some cases, the feature is a coating (e.g., a surface coating) comprising one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more) biomaterials. Retaining features can be applied as shown in the device, or they can be applied as features to other devices described herein. Retaining features may be useful for devices of the present invention designed to remain in the female vagina for an extended period of time (e.g., at least 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months).

[0090] The intravaginal device includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) sensors located within the body (e.g., in a generally annular form) and / or the tether, the sensors being configured to detect muscle movements, e.g., PFL and / or PFR. In some cases, the sensors can be configured to detect muscle movements, e.g., PFL and / or PFR, substantially in real time. In some cases, the sensors (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more sensors) can be selected from the group consisting of: motion sensors, orientation sensors, accelerometers, gyroscopes, micro-electro-mechanical system (MEMS) sensors (e.g., MEMS accelerometers), gravity sensors, tilt sensors, rotation sensors, pressure sensors, light detection sensors (e.g., LiDAR sensors), EIM sensors, and combinations thereof. The device can also include a light generating component for use with a light detection sensor such as a LiDAR sensor. The device can also include electrodes for use with an EIM sensor. Additionally, the intravaginal device can include one or more sensors (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more sensors) configured to detect levels or changes in levels of, e.g., muscle strength, muscle mass, biomolecules (e.g., hormones and / or toxins), pH, temperature, and / or humidity.

[0091] In some cases, the sensors may be positioned in an arrangement similar to or different from the arrangements described in, for example, International Publication Nos. WO2015103629A1, WO2016067023A1, and WO2016042310A1; U.S. Publication Nos. US20150032030A1, US20140066813A1, US20150151122A1, US20150133832A1, US20160008664A1, and US20150196802A1; and U.S. Patent Nos. US8983627, US7955241, US7645220, US7628744, US7957794, US6264582, and US6816744, each of which is incorporated herein by reference. For example, two or more sensors as described herein may be placed around the longitudinal axis of the intravaginal device, such as in a circular or helical pattern around the central axis of the body and / or tether of the intravaginal device, at approximately ±1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, or 270° relative to each other. Alternatively or additionally, two or more sensors as described herein may be placed, for example, spaced apart along the circumference of the body and / or along the length of the tether of the intravaginal device by about 0.001 mm, 0.01 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 125 mm, 150 mm, 175 mm, 200 mm, 225 mm, 250 mm, 275 mm, 300 mm, 325 mm, 350 mm, or further. In some cases, two or more sensors as described herein may be placed along the central axis of the body and / or tether of the intravaginal device. In some cases, two or more sensors as described herein may be placed such that they are not on the central axis, for example, such that they are offset from the central axis of the body and / or tether of the intravaginal device. In certain cases, such as when the sensor is located within the tether, the body may not contain a sensor.In other cases, when the sensor is located within the tether, the body may also include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) sensors. In some cases, the sensor is an accelerometer, such as a multi-axis accelerometer. In other cases, the sensor is a gyroscope, such as a multi-axis gyroscope. In other cases, the sensor is a MEMS sensor. Additionally, the intravaginal device may further include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20 or more) additional sensors within the body and / or the tether, the additional sensors selected from the group consisting of: pressure sensors, muscle mass sensors, muscle strength sensors, biomolecular sensors (e.g., hormone sensors and / or toxin sensors), temperature sensors, moisture sensors, humidity sensors, electromyography (EMG) sensors, and pH sensors. The sensors may be positioned on the surface of the intravaginal device (e.g., on the surface of the body and / or the tether) such that all or a portion of the sensor is in direct contact with the tissue of the individual's vaginal wall and / or cervix or vaginal stump. In some cases, the sensors may be positioned about 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm or further away from the outer surface of the intravaginal device (e.g., the surface in direct contact with the tissue of the individual's vaginal wall and / or cervix or vaginal stump). In some cases, the sensors may be positioned such that about 0.001 mm, 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm or more of the sensor protrudes from the outer surface of the intravaginal device (e.g., the body and / or the tether of the intravaginal device). Alternatively, the sensors may be positioned within the intravaginal device (e.g., within the body and / or the tether) such that the sensors do not directly contact the individual's vaginal wall and / or cervix or vaginal stump, but are positioned to detect movement when the user performs a PFL or PFR. The sensors may be positioned evenly or unevenly at intervals on or within the intravaginal device.Sensors within the intravaginal device (e.g., within the body and / or tether) can be positioned such that when the intravaginal device is inserted into the user's body, the sensors face the abdominal direction (e.g., the anterior direction).

[0092] The tether can have a length of up to about 20 cm (e.g., 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm) and can be divided along its length into multiple segments that contain sensors. The sensors can be positioned at uniform or non-uniform intervals along the length of the tether, e.g., at intervals of about 1 mm to about 140 mm (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 110 mm, 120 mm, 130 mm, or 140 mm). The position of the sensors within the tether can be identified externally of the device by the presence of markings (e.g., protrusions, symbols, writing, and / or etching) on the surface of the tether.

[0093] The intravaginal device (e.g., the body (e.g., in a generally annular form) and / or the tether) further includes a microcontroller within the generally annular form, the microcontroller being configured to receive data from the sensors. The microcontroller can also be configured, or can include separate components, for non-transiently storing data from the sensors. The microcontroller can be connected to the sensors, for example, by wires and / or a circuit board. The wires and the circuit board can be flexible or rigid.

[0094] The intravaginal device can also include a transmitter and a receiver within the body (e.g., in a generally annular form) and / or in the form of the tether for communicating wirelessly or via a detachable cable with an electronic device (e.g., a peripheral device, such as a handheld or portable device or a computer, such as a smartphone, a tablet, or a laptop). Alternatively, the transmitter and the receiver can be located in a housing and be connected to the intravaginal device wirelessly or via a detachable cable. The transmitter and the receiver can be directly or indirectly connected to the microcontroller, the sensors, and / or the circuit board. The transmitter and the receiver can be configured to be used with electronic devices that support Bluetooth, ISM, and / or Wi-Fi and / or RF. Information collected by the sensors can be wirelessly transmitted (e.g., downloaded, transferred) to the electronic device by the transmitter and the receiver and / or by using a detachable cable.

[0095] In addition, the intravaginal device may include a peripheral device that may be configured with a processing unit that may transform or utilize sensor data received from the intravaginal device when the subject performs pelvic floor exercises, such as during daily activities (e.g., activities that change (e.g., increase and / or decrease) the overall health of her urogenital system and / or pelvic floor), to provide feedback to the subject regarding whether the detected activity affects her health status or indicates treatment or treatment need for UI and / or FI. For example, the peripheral device may process the sensor data to generate a baseline that may be used to compare with sensor data obtained at a future time to provide feedback (e.g., an alert) to the subject regarding whether the activity she performs is beneficial or harmful to her health condition, or whether the pelvic floor exercise indicates treatment or treatment need for UI. Additionally, or alternatively, the peripheral device may process the sensor data and compare the result with a previously established or predetermined baseline, and based on the comparison, may provide feedback (e.g., an alert) to the subject regarding whether the activity performed is beneficial or harmful to her health condition, or whether the pelvic floor exercise indicates treatment or treatment need for UI.

[0096] Additionally, the electronic device may include a user interface. The user interface may be programmed to display data and / or provide instructions for use of the intravaginal device. The intravaginal device further includes a power source (e.g., a battery). The power source may be used to operate one or more components of the device, such as sensors, transmitters, receivers, and circuit boards. In some cases, the power source is located within the generally annular form of the intravaginal device and is connected to the components via wires and / or circuit boards.

[0097] Exemplary intravaginal devices of the present invention are depicted in Figure 3 and 4. Figure 3Depicts an intravaginal device 100 having a body 110 and a tether 10. The tether 10 can include, for example, 1 - 20 sensors 200 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or more sensors 200). The body 110 can also include, for example, 1 - 20 sensors 200 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or more sensors) and 1 - 20 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or more) energy emitters 210 (e.g., RF, laser, electrical stimulation). The tether 10 or the body 110 can be flat or rectangular. The sensors in the tether 10 can be MEMS sensors. The tether 10 can also include a Bluetooth chip and / or an Apple chip or other wireless - compatible chipset. The body 110 can be configured to administer at least one (e.g., 1, 2, 3, 4, 5 or more) medicament to vaginal tissue to treat PFD, vaginal disorders or their symptoms, or other diseases or conditions. In some cases, the tether 10 can be similarly configured to administer a medicament to vaginal tissue. Constructing the tether 10, which is detachable from the body 110, for drug administration will provide the user with the option to replace and / or change the tether as needed, e.g., when the medicament has been depleted, when a different medicament is needed, or when a different dose is needed, without having to discard the body 110. The tether 10 can have graduations or scale markings to visualize how deep the intravaginal device 100 is within the vagina. In any of the embodiments described herein, the tether can optionally be absent.

[0098] The intravaginal device 100 includes at least one sensor 200 within the tether 10 for monitoring pelvic floor muscle movement. As Figure 3As shown, the intravaginal device 100 includes a circuit board 700 within a body 110. The circuit board 700 can be a flexible circuit board that connects multiple components of the intravaginal device 100 to each other, and the multiple components are such as a sensor 200, a battery 800, a microcontroller 900, a transmitter / receiver 1000, a data storage unit 1100, a sensory output component 1200, a wireless communication antenna 1300, an ON / OFF switch 1600, and an authentication chip 1400 ( Figure 3 , illustration). The circuit board 700 can also alternatively be connected to the sensor 200 by wires. The circuit board 700 and all its connected components can alternatively be positioned within a tether 10. The intravaginal device 100 can be constructed with additional sensors and / or delivery modules.

[0099] The intravaginal device 100 can be manually inserted or inserted using an insertion tool into the vagina of a subject and deployed substantially parallel to the upper vaginal surface adjacent to the pelvic floor at a position near the cervix, vaginal vault, or vaginal stump. The intravaginal device 100 can also include molded wings 300 for stabilizing the device at a position near the cervix or vaginal stump of the subject ( Figure 3 ). The tether 10 can also be in the form of a detachable cable that can be used to connect the intravaginal device 100 to a transmitter / receiver box 500 and assist in removing the intravaginal device 100 from the subject.

[0100] In certain embodiments, the intravaginal device 10 includes 8 or fewer (e.g., 4 or 5) sensors 200 within the tether 10 and 5 or fewer sensors 200 within the body 110. Both the tether and the body can share a sensor ( Figure 4). The angle between the plane connecting the front and rear sides of the main body 110 and the tether 10 can vary from 0° - 180° (e.g., 10º, 20º, 30º, 40º, 50 º, 60º, 70º, 80º, 90º, 100º, 110º, 120º, 130º, 140º, 150º, 160º, 170º, 180º). The perimeter of the main body 110 can range from about 10 cm to about 50 cm (e.g., 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm or 50 cm), or it can be 27.6 cm. The length of the tether 10 can range from about 1 cm to about 50 cm (e.g., 2 cm, 3 cm, 4 cm, 5 cm, 10 cm, 15cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm), or it can be 25.5 cm long. The sensors 200 can be spaced apart from about 0.5 cm to about 5 cm (e.g., 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm or 4.5 cm), or they can be spaced apart by about 1.6 cm. At least one sensor 200 can be placed on the tether within 10 cm or less from the main body 110 (e.g., 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm or 1 cm).

[0101] Intrarectal device

[0102] The present invention also features an intrarectal device that can be used as, for example, a system having the urodynamic catheter described herein. The intrarectal device having an elongate body described herein can be used as part of a system for monitoring pelvic floor movement during, before, or after urodynamic testing, or for generating a voiding diary alone or in combination with a urodynamic catheter or a vaginal device. Exemplary intrarectal devices are described in, for example, U.S. Publication Nos. US20170281072 and US20170303843, the entire disclosures of which are hereby incorporated by reference herein.

[0103] The device can be inserted into the rectum of a subject (e.g., a male or female subject) such that one or more position sensors provide spatially oriented position readings of the subject's rectum. The position of the rectum provides readings that serve as a surrogate for the position of the pelvic floor and the spatial arrangement of pelvic floor organs including the urethra and prostate. The intra-rectal device can include a plurality of position sensors (e.g., MEMs accelerometers) positioned along the length of the device. The intra-rectal device can also include one or more additional sensors such as motion and / or pressure sensors. The intra-rectal device can be structurally configured in any suitable geometry to fit within the rectum of the subject.

[0104] The intra-rectal device can be used in combination with a urodynamic catheter during urodynamic testing to detect patterns of angular change. For example, specific sensors in the intra-rectal device can be monitored during urodynamic testing to assess patterns and angular changes in the pelvic floor as a surrogate for assessing pelvic floor muscle physiology. To accurately diagnose pelvic floor disorders in the tested subject, the patterns and angular changes can be compared to those observed prior to diagnosing or treating the tested subject or a subject with a known pelvic floor disorder (e.g., urinary incontinence).

[0105] Trends and patterns of angular change of sensors (e.g., MEMS accelerometers) observed in the urodynamic catheter and the intra-rectal device during urodynamic testing can be used to diagnose or predict disease states based on the position, movement, and relative orientation of pelvic floor muscles (e.g., various levator ani and anal sphincter muscle groups) and / or pelvic floor organs, or to assess the efficacy of a selected therapy in a subject.

[0106] Systems and kits

[0107] The invention also features systems and kits that include a urodynamic catheter and optionally an intra-vaginal and / or intra-rectal device for diagnosing, preventing, and / or treating pelvic floor disorders (PFDs), such as urinary incontinence. Kits configured to serve as an automated voiding diary can also be used. These kits can be used to treat an individual (e.g., a male or female subject) who can benefit from enhanced urodynamic testing by monitoring pelvic floor muscle movement. In some cases, the kit can include a device of the invention configured to monitor the overall health status of the user's urogenital system and / or pelvic floor (e.g., the muscle fibers of the levator ani, such as the pubococcygeus, iliococcygeus, coccygeus, puborectalis, and associated connective tissue). In any of the kits or systems described herein, the urodynamic catheter, intra-vaginal device, and / or intra-rectal device can be configured with or without position sensors.

[0108] The system or kit may include a urodynamic catheter, an intravaginal device and / or an intrarectal device, as well as one or more of a transmitter and receiver, a detachable cable, an electronic device, a database and / or a user interface, a power source (e.g., one or more batteries), and instructions for their use. Additionally, the kit may contain, for example, a charger, a hygiene cleaner, and / or gloves.

[0109] Other optional components of the kit include a lubricant for insertion into the urethral, rectal, or intravaginal device (e.g., a lubricant compatible with the material of the intravaginal device, e.g., silicone) and / or a biomaterial (e.g., hyaluronic acid) for improving the adhesion of the device at a location near the cervix or vaginal stump, rectum, or urethra / bladder of an individual. Optional components (e.g., lubricant and / or biomaterial) may be provided in separate containers (e.g., sealed packages, tubes, and / or applicators).

[0110] Alternatively, optional components (e.g., lubricant and / or biomaterial) may be provided as pre-applied to the device such that the device is ready for insertion and use. Additional optional components of the kit include sterile gloves (e.g., at least one pair of sterile gloves) for inserting and / or removing the device or alternatively for use during application of the lubricant and / or biomaterial to the device, and / or a storage container for the devices and / or systems of the present invention.

[0111] The kits of the present invention can be used for diagnosing and / or treating pelvic floor disorders such as, but not limited to, urinary incontinence (UI), detrusor incontinence (DI), stress urinary incontinence (SUI), urge urinary incontinence (SI), intrinsic sphincter deficiency (ISD), mixed stress and urge urinary incontinence, dysuria (e.g., painful urination), and anal or fecal incontinence.

[0112] Voiding diary

[0113] A voiding diary is a log traditionally maintained manually by a subject (e.g., male or female subject) suffering from urinary incontinence that tracks fluid input and urine output and associated characteristics. The present invention features that an automated voiding diary can be generated using a urodynamic catheter, an intravaginal device and / or an intrarectal device and their systems. In some embodiments, the intravaginal device or the intrarectal device can be used alone to create an automated voiding diary. The intravaginal device will be used for female subjects, while the intrarectal device can be used for male or female subjects.

[0114] A voiding diary includes information such as fluid intake, voiding frequency, volume (e.g., of urine) per void, duration, quality, number of trips to the restroom (e.g., due to strong, sudden urges), number of accidents, number or severity of urine leaks, number of pad or diaper changes, and number of clothing changes. Additionally, the voiding diary can include a time log tracking each of these events throughout the day and can be maintained over a diagnostic and / or treatment period of, for example, 1 week to 6 months (e.g., 2 weeks, 3 weeks, 4 weeks, 2 months, 3 months, 4 months, 5 months, 6 months) or longer. Each event recorded in the voiding diary is tracked by automatic detection of the event by position sensors and / or other sensors of a urodynamic catheter, intravaginal device, and / or intrarectal device. As described in more detail herein (see, e.g., "Methods of Detecting Pelvic Floor Movements" above), different pelvic floor movements associated with voiding, urges, maneuvers, coughing, Valsalva, reflex levator responses during urgency / urge suppression, and / or other pelvic floor muscle contractions exhibit characteristic sensor angle patterns that can be associated with these specific events. Sensors that communicate with, for example, a peripheral device and / or a processor can then be used to track the occurrence of each event and timestamp the event. Additionally, a urodynamic catheter, intravaginal device, and / or intrarectal device can provide a marker, such as the volume of urine produced during a voiding event, thereby eliminating the need to classify each voiding episode as small, medium, or large. The peripheral device can include an electronic device that includes a display interface or communicates with an electronic device that includes a display interface. The display interface can provide information about urinary episodes (e.g., voiding or urinary urgency during the last pelvic floor contraction) to the user. The display interface (e.g., a smartphone or tablet) can include an application that provides a streamlined visual display of the voiding diary information and the above-described markers. The application can include allowing the subject to confirm the characteristics of a voiding episode. For example, the application can interpret patterns generated by an accelerometer, associate the patterns with specific events, and then ask the user to confirm the episode identified by the device. Thus, these devices can be used as a system in a method for accurately tracking episodes associated with voiding and urinary incontinence in order to provide a reliable log of the events. The recorded events can be used to assist in diagnosing pelvic floor disorders, such as urinary incontinence, and in methods of treating these disorders in subjects in need thereof.

[0115] Example

[0116] The following examples are presented to provide a description to a person of ordinary skill in the art of how to carry out, make, and evaluate the devices, systems, and methods described herein and are intended purely as examples of the devices, systems, and methods and are not intended to limit the scope of what the inventors regard as their invention.

[0117] Example 1. Urodynamic testing using a urodynamic catheter with a position sensor

[0118] Female subjects with urinary incontinence use a urodynamic catheter with a position sensor during urodynamic testing ( Figure 1 ). The urodynamic catheter includes a plurality of MEMS accelerometers positioned along the length of the device. The doctor inserts the catheter into the subject, and the subject urinates. The catheter measures the flow and electrical activity of the muscles and nerves of the pelvic floor using electromyography ( Figure 2 ). The catheter also measures detrusor pressure, bladder pressure, abdominal pressure, and the fluid volume in the bladder. The position sensor on the catheter provides detailed visual information during bladder filling, emptying, and Valsalva. Characteristic patterns observed from the accelerometer readings indicate that the subject has hypermobility of the urethra.

[0119] Intravaginal and / or intrarectal devices can also be used during urodynamic testing to obtain additional data on pelvic floor muscle movement and provide a more comprehensive diagnosis of the type and severity of urinary incontinence.

[0120] Example 2. Detection of pelvic floor movement using an algorithm

[0121] An intravaginal device with a plurality of MEMS accelerometers is inserted into the vagina of a female subject, and the subject is asked to perform a series of pelvic floor movements (e.g., pelvic floor lift, pelvic floor relaxation, Valsalva maneuver, sustained pelvic floor lift, and continuously repeated pelvic floor lifts). Sensor angles (relative to the horizon) and position data are collected from each MEMS accelerometer. The angular data from each sensor is plotted as a function of time ( Figure 6 ).

[0122] Two composite scores Y1 and Y2 are calculated from the angles (A) of sensors S5 - S7:

[0123] Y1 = A5 + A6 + 0.6 × A7

[0124] Y2 = A5 + A6 – 0.8 × A7

[0125] Moving averages (Y1_movmean and Y2_movmean) of Y1 and Y2 are calculated from three consecutive samples of Y1 and Y2. A moving average filter is used to reduce noise and minimize false positives. The filtered composite scores are plotted relative to time ( Figure 7A ), and the derivative of these data is plotted as the change in sensor angle relative to time ( Figure 7B ). When the change in sensor angle relative to time exceeds a threshold of 18º, a pelvic floor lift is determined to have occurred. This threshold can be determined byFigure 7A The slope of the curve in Figure 7B and the dashed line in Figure 7A are used for visualization. The value of 18º was determined empirically based on data from 10 different subjects. At the instant when the time derivative of the moving average Y1 or Y2 exceeds this threshold, the start of pelvic floor elevation is determined. The peaks of the moving averages Y1 and Y2 are denoted as Y1_max and Y2_max. The increases in the moving averages Y1 and Y2 are denoted as ΔY1 = Y1_max – Y1_start and ΔY2 = Y2_max – Y2_start ( Figure 7B ). These values indicate the amplitude of pelvic floor elevation. When the Y1_movmean drops below the value of Y1_max - 0.5 × ΔY1 or the Y2_movmean drops below the value of Y2_max - 0.5 × ΔY2, the end of pelvic floor elevation is determined. The start and end times are also related to the moment when the second derivative of the sensor angle with respect to time reaches zero, as shown by the top and bottom of the spikes at approximately 42 seconds and 55 seconds in

[0126] As shown in the graph, the same data analysis is repeated for all pelvic floor movements (pelvic floor elevation, pelvic floor relaxation, Valsalva maneuver, sustained pelvic floor elevation, and continuously repeated pelvic floor elevation).

[0127] Example 3. Detection of pelvic floor movements during daily activities as a measure of the user's health status

[0128] The user can insert a vaginal device with multiple MEMS accelerometers into her vagina, and the device can detect pelvic floor movements (e.g., pelvic floor elevation, pelvic floor relaxation, Valsalva maneuver, sustained pelvic floor elevation, and continuously repeated pelvic floor elevation) during her daily activities. A processor in the device or in a peripheral device such as a smartphone or a wearable device (e.g., a watch) can process the data to calculate the occurrence of pelvic floor events. Each MEMS accelerometer emits a signal corresponding to the position relative to the horizon and the sensor angle. The angular data from each sensor is plotted as a function of time. The intensity of the signal from each sensor is represented by the change in angle (angle during pelvic floor elevation - angle during pelvic floor relaxation). This signal intensity is used to determine which sensors provide the strongest signal. This process is repeated for 10 subjects ( Figure 8 ).

[0129] Parameter D MN is defined as the "increment" of the angle of sensor M of subject number N. SM is defined as the angle of sensor M. The optimized composite score is defined as Y opt_N = sum (1:10){D MN × S M}. Thus, the optimized composite score is a weighted average based on the relative signal strength of each sensor, which varies depending on the subject. In Figure 7A to 7B, the optimized composite score for the first subject is given by Y opt_1 = -1.1S 1 - 1.8S 2 + 1.2S 3 + 7.6S 4 + 6.9S 5 – 3.1S 6 – 10.2S 7 – 8.7S 8 – 5.1S 9 – 4.8S 10 is given. The optimized composite scores for the other subjects (2 - 10) are calculated in a similar manner.

[0130] Although the data in this example was generated by an intravaginal device, the same type of data could also be generated by a urodynamic catheter with an accelerometer.

[0131] Example 4. Maintaining an Automated Voiding Diary

[0132] Subjects with urinary incontinence use the system of the present invention, which includes a urodynamic catheter that supports a position sensor ( Figure 1 ) and / or an intravaginal device that includes multiple MEMS accelerometers, to automatically monitor and record characteristic pelvic floor movements associated with urination and filling, reflex levator responses during urgency and urge suppression, and maneuvers during coughing and Valsalva, which are generated by the MEMS sensors of the device. A timestamp can be assigned to each event, which provides both the frequency and duration information of each episode. The urodynamic catheter can be used to measure the volume of each voiding event, and the volume of each voiding event can also be recorded in the automated voiding diary. Then, this information can be used to determine the pattern of incontinence episodes in order to diagnose the subject or to track the efficacy of a treatment regimen.

[0133] Alternatively, the subject can generate a voiding diary using only a vaginal device with a MEMS accelerometer. The device can be inserted into the subject's vagina and remain there for up to four weeks during which she generates an automated voiding diary. Each urinary episode is monitored by sensors on the vaginal device, which tracks characteristic pelvic floor movements associated with voiding and filling, reflex levator responses during urgency and urge suppression, and maneuvers during coughing and Valsalva. A timestamp can be assigned to each event, which provides information on both the frequency and duration of each episode. This information can then be used to determine patterns of incontinence episodes in order to diagnose the subject or to track the efficacy of a treatment regimen.

[0134] Other embodiments

[0135] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated herein by reference.

[0136] Although the invention has been described in connection with specific embodiments thereof, it will be understood that the invention is capable of further modifications, and this application is intended to cover any variations, uses, or modifications of the invention, generally following the principles of the compositions and methods of the invention, and including such departures from the present disclosure as come within the known or customary practice in the art to which the invention pertains and can be applied to the essential features set forth above and fall within the scope of the claims. Other embodiments are also within the scope of the claims.

Claims

1. A system comprising a urodynamic catheter and an intravaginal or intrarectal device, the urodynamic catheter comprising a plurality of lumens and a plurality of position sensors positioned along the length of the catheter, the intravaginal or intrarectal device comprising a plurality of position sensors positioned along the length of the device, and wherein each of the urodynamic catheter and the intravaginal or intrarectal device comprises a transmitter and / or receiver for transmitting position data including sensor angle and time to an electronic device; wherein each of the urodynamic catheter and the intravaginal or intrarectal device is configured to transmit position data to an electronic device for monitoring bladder function of a subject, wherein the position data is capable of being processed by the electronic device to detect, diary, and differentiate bladder function, the bladder function including one or more of: voiding, urge, knack, cough, Valsalva, reflex levator response, pelvic floor muscle contraction, filling, emptying, capacity, sensation, compliance, and leakage; in, The intravaginal or intrarectal device is used in combination with the urodynamic catheter during urodynamic testing to detect patterns of angular changes.

2. The system of claim 1, wherein the plurality of position sensors are MEMS accelerometers.

3. The system of claim 1, wherein the urodynamic catheter, intravaginal device, and / or intrarectal device comprises 2 to 50 sensors.

4. The system of claim 3, wherein the urodynamic catheter, intravaginal device, and / or intrarectal device comprises 2 to 20 sensors.

5. The system of claim 1, wherein: a) the intravaginal device comprises: a generally annular body having an outer edge configured to contact a vaginal wall or vaginal vault; and a tether connected to the body; or b) The intrarectal device comprises: a generally annular body having an outer edge configured to contact the rectum; and a tether connected to the body.

6. The system of claim 1, wherein the urodynamic catheter, intravaginal device, and / or intrarectal device has a length of 2 cm to 50 cm.

7. The system of claim 1, wherein the transmitter or receiver is a radio frequency transmitter or receiver.

8. The system of claim 1, wherein the transmitter and / or receiver can transmit the data to the electronic device wirelessly.

9. The system of claim 1, wherein the transmitter and / or receiver are configured for use with electronic devices supporting Bluetooth, ISM (Industrial, Scientific, and Medical) band radio, and / or Wi-Fi.

10. The system of claim 1, wherein the electronic device comprises a display.

11. The system of claim 10, wherein the display is a graphical user interface.

12. The system of claim 10, wherein the display is a graphical user interface having a touch user interface.

13. The system of claim 1, wherein the electronic device is a computer, a tablet, a smartphone, or a smart watch.

14. The system of claim 1, wherein: The urodynamic catheter is configured to perform one or more urodynamic measurements for assessing bladder function of a subject.

15. The system of claim 14, wherein the one or more urodynamic measurements measure one or more of position, motion, pressure, and flow.

16. The system of claim 15, wherein the pressure comprises one or more of intra-abdominal pressure, detrusor pressure, and intra-vesical pressure.

17. A kit comprising the system of claim 1, and instructions for use.

18. The kit of claim 17, wherein the kit is configured for use as an automatic urination diary.

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