System and method for monitoring pelvic floor-associated perineal movements

Abstract

System and method for monitoring pelvic floor-associated perineal movements to track and / or gamify pelvic muscle exercise for the purpose of improving pelvic muscle function in treatment of urinary incontinence (UI) and other pelvic floor dysfunctions. A non-invasive perineal movement detection device is configured for external arrangement flush against the perineum of the subject. A computer device is configured for communication with the perineal movement detection device. A placement element fixes the perineal movement detection device in an anatomically relevant position relative to the user during use of the system.

Description

[0001] SYSTEM AND METHOD FOR MONITORING PELVIC FLOOR-ASSOCIATED PERINEAL MOVEMENTS

[0002] Field of the Invention

[0003] The invention generally relates to medical devices for and / or methods for strengthening muscles of the pelvic floor, particularly to a system and method for monitoring pelvic floor- associated perineal movements, and most particularly to a system and method for externally monitoring orientation of the perineum during contraction / release of the pelvic floor muscles to track and / or gamify pelvic muscle exercise for the purpose of improving pelvic muscle function in treatment of urinary incontinence (UI) and other pelvic floor dysfunctions.

[0004] Background

[0005] The pelvic floor includes a network of muscles and ligaments located at the base of the abdomen which function to support internal organs such as the uterus, bladder, intestines, and rectum. Although pelvic floor dysfunction affects both men and women, it is a particularly sensitive issue for women. Anatomy of the human female pelvic floor showing normal muscles and positioning of internal organs is illustrated in FIG. 1. Multiple factors and / or conditions can contribute to weakening of the pelvic floor muscles such as pregnancy, childbirth, aging, surgery, chronic coughing, excessive straining due to constipation, and being overweight1,2. Anatomy of the human female pelvic floor showing weakened (loose) pelvic floor muscles and out-of-place internal organs is illustrated in FIG. 2.

[0006] Pelvic floor dysfunction decreases quality of life and can lead to medical complications of increasing severity. For example, involuntary leakage of urine due to weakness of pelvic floor muscles (urinary incontinence) is such a complication that affects both men and women. Urinary incontinence (UI) is prevalent for women in the U.S. wherein approximately 23 million women ages 50-80 and approximately 1.2 million new mothers suffer with this condition.

[0007] Repetitive pelvic muscle contractions (clench-and-release exercises, aka "Kegels") are the “gold standard’7of pelvic floor restoration and are often recommended as an initial step in management of urinary incontinence. Although clinically proven as effective to strengthen the muscles of the pelvic floor, women often avoid Kegels as they are difficult to perform correctly and most available methods for monitoring correct performance require uncomfortable internal devices. Thus, a new approach to empower women to rejuvenate and regain control of their pelvic floor in an engaging, non-invasive way is needed. Summary

[0008] The invention provides this needed new approach. During a contraction of the pelvic floor, the orientation of the perineum changes by lifting in the cranial / ventral direction, and during the release or strain of the pelvic floor, the orientation of the perineum changes by dropping in the caudal / dorsal direction. The herein described system and method involve monitoring this change in orientation of the perineum and include recognizing pelvic floor contraction and release / strain of a subject throughout sessions of voluntary pelvic floor contractions (Kegel exercises or “Kegels’"), in which a perineal movement detecting device is externally situated against the subject’s perineum.

[0009] The terms “pelvic floor exercises”, “voluntary pelvic floor contractions”, "‘pelvic contractions”, “Kegel exercises”, and “Kegels” are used interchangeably herein.

[0010] The systems and methods described provide a new paradigm for monitoring performance of Kegel exercises to improve their effectiveness at strengthening muscles of the pelvic floor.

[0011] In a general aspect, the invention provides an engaging new way of performing Kegel exercises. In a general aspect, the invention provides a more effective way of performing Kegel exercises. In another general aspect, the invention provides devices and methods for external monitoring of pelvic floor movement.

[0012] In an aspect, the invention provides a system for externally monitoring orientation of a perineum of a subject during a contract! on / rel ease of pelvic floor muscles of the subject. When using this system concurrently with an exercise session, a subject is able to determine whether they are performing Kegel exercises correctly and thus, the subject is able to adjust their technique if necessary. In this way, a subject has a more beneficial exercise session. Although preferably a human female, a subject to benefit from the inventive system and method is not limited thereto. A “subject” refers to any human or animal that can benefit from the systems and methods disclosed herein. A “subject” may also be referred to as a “patient.” The system includes, but is not limited thereto, a perineal movement detection device configured for external arrangement flush against the perineum of the subject; a computer device configured for communication with the perineal movement detection device; and a placement pad configured for enclosing the perineal movement detection device and fixing the perineal movement detection device to a location on an undergarment of the subject such that orientation of the perineal movement detection device relative to a sagittal axis of the perineum of the subject is maintained during use of the system. The computer device can communicate with the perineal movement detection device wirelessly or via a wired communication interface. The perineal movement detection device includes a set of elements, including but not limited thereto, a perineal accelerometer, a processor, a transceiver, and a control accelerometer. These elements can be included individually or in any combination.

[0013] The computer device includes a set of elements, including but not limited thereto, a transceiver, a memory, a processor, and a user display. These elements can be included individually or in any combination.

[0014] The elements of the perineal movement detection device can be enclosed or encased within a housing. The housing can be divided into regions including, but not limited thereto, an electronics region at a first end; a perineal sensing region at an end opposite the first end; and a connection strip configured as a spacer and a connection between the electronics region and the perineal sensing region. In an embodiment, the perineal sensing region has a smaller width than a width of the electronics region.

[0015] The placement pad can be divided into regions corresponding to the regions of the housing; for example, but not limited thereto, an anterior region corresponding to the electronics region of the housing; a posterior region corresponding to the perineal sensing region of the housing; and a connection strip corresponding to the connection strip of the housing. Although a placement pad is used in exemplary embodiments, the disclosure envisions the use of any suitable device for fixing the perineal movement detection device relative to a sagittal axis of the perineum of the subject.

[0016] In an aspect, the placement pad is constructed of connected layers having an opening at one end. An embodiment of the layers includes an adhesive layer and a sanitary' layer. The adhesive layer attaches the perineal movement detection device to the undergarment of the subject. A non-limiting example of a placement pad includes an adhesive layer on one surface configured for fixing the perineal movement detection device to the location on the undergarment of the subject, a sanitary layer having a same shape as the adhesive layer and connected to the adhesive layer along a perimeter of the adhesive layer to form an interior space configured to enclose the perineal movement detection device between the adhesive layer and the sanitary layer, and an opening to the interior space at the anterior region configured for insertion of the perineal movement detection device.

[0017] In an aspect of the system, the perineal movement detection device includes a perineal accelerometer arranged in the perineal sensing region of the housing. The perineal accelerometer is configured for externally monitoring orientation of the perineal sensing region.

[0018] In an aspect of the system, the perineal movement detection device includes a control accelerometer arranged in the electronics region of the housing. The control accelerometer is configured for sensing non-perineal movements of the subject and for removing signals due to the non-perineal movements from the perineal accelerometer. The control accelerometer functions to ensure that the perineal movement detection device measures only true movements of the perineum of the subject.

[0019] In an aspect of the system, the perineal movement detection device includes a processor and a transceiver arranged in the electronics region of the housing. The transceiver is configured to receive data from the computer device and to transmit data to the computer device.

[0020] In another aspect of the system, the computer device includes a transceiver, a processor, and a user display. The transceiver is configured to transmit data to and receive data from the perineal movement detection device and the user display is configured to convey output data from the processor to the subject using the system.

[0021] In another aspect of the system, the computer device includes a memory and system configuration programs. In another aspect of the system, the memory includes data storage, such as but not limited to, a data bucket.

[0022] In yet another aspect of the system, the memory of the computer device includes certain elements, including but not limited to, a calibration module, an initiation detection module, and an orientation detection module. These elements can be included individually or in any combination. The calibration module is configured for generating parameters for calibrating processing implemented by the system; the initiation detection module is configured to detect initiation of pelvic floor muscle movement and to commence a measurement period, during which time orientation of the perineum of the subject is monitored; and the orientation detection module is configured to process orientation data to determine a direction of rotation of the perineal movement detection device during the measurement period and to generate an output indicating that there has been either a contraction or release of pelvic floor muscles of the subject. The output can include a series of data points taken at different times of the measurement period.

[0023] In another aspect of the system, the computer device includes a gaming app; for example, but not limited to, a gaming app based on non-invasive Kegel biofeedback. The gaming app allows the subject to make Kegel exercise a game and thus less monotonous. Subjects are more likely to exercise consistently if exercise is a fun and engaging game.

[0024] In another embodiment, the elements used in the inventive system can be packaged in containers and assembled in kits together with instructions for use. Non-limiting examples of these elements are a perineal movement detection device, a plurality of placement pads, and a computer device. Kit elements are physically associated in or with one or more containers and considered as a unit for manufacture, distribution, sale, or use. All or some of the elements of the inventive system can be packaged as kits. In an aspect, the invention provides a method for externally monitoring orientation of a perineum of a subject during contraction / release of pelvic floor muscles using the inventive system described herein and employing the system concurrently with their exercise routine.

[0025] In another aspect, the invention provides a method for externally monitoring orientation of a perineum of a subject during a contraction / release of pelvic floor muscles including inserting a perineal movement detection device into a placement pad such that the perineal movement detection is enclosed in an interior of the placement pad; attaching the placement pad to an undergarment such that a posterior region of the placement pad corresponds to a perineal sensing region of the perineal movement detection device; initiating a series of voluntary pelvic floor contractions beginning a measurement period; monitoring the orientation of the perineum during the series of voluntary pelvic floor contractions; and processing orientation data thereby generating an output signal indicating if there has been a contraction or release of the pelvic floor muscles during the measurement period. The method can also include adjusting exercise technique if the output signal indicates that Kegels are being performed incorrectly.

[0026] The inventive method can be used for detecting Kegel exercises externally, re-gaining urinary' continence, strengthening muscles of the pelvic floor, regaining control of the muscles of the pelvic floor, and / or treating urinary' incontinence and other pelvic floor dysfunctions.

[0027] Other objectives and advantages of this invention will become apparent from the following description, wherein are set forth, by way of example, certain embodiments of this invention.

[0028] Brief Description of the Drawings

[0029] A more complete understanding of the present invention may be obtained by references to the accompanying drawings when considered in conjunction with the subsequent detailed description. Any embodiments illustrated in the drawings are intended only to exemplify the invention and should not be construed as limiting the invention to the illustrated embodiments.

[0030] FIG. 1 is an illustration of the anatomy of the human female pelvic floor showing normal pelvic floor muscles and positioning of internal organs.

[0031] FIG. 2 is an illustration of the anatomy of the human female pelvic floor show ing loose / weakened / dysfunctional pelvic floor muscles and out-of-place internal organs.

[0032] FIG. 3 is an illustration of the application of the perineal movement detection device in an undergarment. The device is inserted into a placement pad and the placement pad is attached to the undergarment. The star indicates the location of the perineal accelerometer.

[0033] FIG. 4 is an illustration of the anatomy of the human female pelvic floor show ing orientation of the deep muscle layer and the superficial muscle layer. The star indicates the location of the perineum. The perineal accelerometer is externally arranged against the perineum. The arrow shows direction of movement during contraction of the pelvic floor.

[0034] FIG. 5 is a graph illustrating an output signal as detected by the perineal movement detection device. The graph shows an output signal for one full Kegel.

[0035] FIG. 6 is an illustration of an embodiment of the perineal movement detection device and its placement pad. The locations of a control accelerometer, a Bluetooth module, and a microprocessor are shown at the large end of the device and the location of a perineal accelerometer is shown at the small end of the device. The separation of components keeps the footprint small at the perineum and more comfortable for the subject.

[0036] FIG. 7 is a schematic illustration of an embodiment of the system configured for monitoring pelvic floor-associated perineal movements. The perineal movement detection device is electronically connected to the computer device.

[0037] FIG. 8 is an illustration of an embodiment of a placement pad attached to an undergarment.

[0038] FIG. 9 is an illustration of an embodiment of a perineal movement detection device prior to its enclosure into a placement pad.

[0039] Detailed Description

[0040] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to embodiments illustrated herein and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modification in the described systems, devices, and / or methods, along with any further application of the principles of the invention as described herein, are contemplated as would normally occur to one skilled in the art to which the invention relates.

[0041] Additionally, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is. unless specified otherwise or clear from context, “X employs A or B” is intended to mean any of the natural inclusive permutations. That is if X employs A; X employs B; or X employs both A and B, then “X employs A or B” is satisfied under any of the foregoing instances.

[0042] In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form. Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word ’‘about” or ‘'approximately” preceded the value of the value or range.

[0043] It should be understood that although the steps of the methods set forth herein can be carried out sequentially such steps are not necessarily required to be performed in the order described, and the order of the steps of such methods should be understood to be merely exemplary. Likewise, additional steps may be included in such methods, and certain steps may be omitted or combined in methods consistent with various embodiments of the present methods and / or devices / sy stems.

[0044] Although the steps / elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to being implemented in that particular sequence.

[0045] System Overview and Method for Use Thereof

[0046] The instant inventors observed that, during a contraction of the pelvic floor, the orientation of the perineum changed by lifting in the cranial / ventral direction, and that during the release or strain of the pelvic floor, the orientation of the perineum changed by dropping in the caudal / dorsal direction. FIG. 4 shows orientation of the deep muscle layer 20 and the superficial muscle layer 22 relative to the location of the perineum which is indicated by star 24. Arrow 26 shows the direction of movement during contraction of the pelvic floor.

[0047] Thus, based upon this observation, the instant inventors developed a system and method for recognizing pelvic floor contraction and release / strain of a female subject throughout sessions of voluntary' pelvic floor contractions, in which a perineal movement detecting device is externally situated against the user’s perineum. The perineal movement detecting device is configured to maintain contact with the perineum such that any movement of the perineum along the sagittal axis during pelvic floor activity will cause a corresponding movement of the perineal movement detecting device. Therefore, the direction of rotation of the perineal movement detecting device relative to the subject can be measured and used to determine whether there has been a pelvic floor contraction or pelvic floor release / strain.

[0048] FIG. 7 illustrates an example embodiment of a system 100 for recognizing pelvic floor contraction and release / strain of a female subject / user throughout sessions of voluntary pelvic floor contractions. The system 100 includes a perineal movement detection device 110, configured to be flush against the perineum of the subject / user and to maintain its orientation relative to the sagittal axis of the perineum, and a computer device 130 configured to communicate with the perineal movement detection device 110. The perineal movement detection device 110 and the computer device 130 are configured to communicate with each other wirelessly, although they could also be configured to communicate via a wired communication interface.

[0049] The perineal movement detection device 110 contains a perineal accelerometer 114 configured to monitor the orientation of the perineal region of the perineal movement detection device 110, a processor 112, and a transceiver 111 configured to transmit and receive data to / from the computer device 130. The perineal movement detection device 110 can further include a control accelerometer 113 configured to sense the subject' s / user’s non perineal associated movements. This could be used to remove signal due to non-perineal motion from the perineal accelerometer 114 signal in real-time during a measurement period. The perineal accelerometer 114 and / or control accelerometer 113 can be replaced by a geomagnetic field sensor / magnetometer, and / or a gyroscopic sensor, or any other sensor that could measure orientation and / or acceleration.

[0050] Although perineal movement detection device 110 is discussed mainly with monitoring orientation, other perineal activity7could be monitored additionally or alternatively. Non-limited examples of perineal activity include position; acceleration; electrical signal from pelvic floor- associated motor neurons; and pressure change between perineum and perineal activitydetecting device.

[0051] As further illustrated in FIGS. 3 and 9 the electronic components of the perineal movement detection device 110 are protected in a durable, flexible electronics housing 115, which has a form factor that allows its perineal region to be easily located along the subject' s / user’s perineum to ensure that this region maintains its orientation relative to the sagittal axis of the perineum. The electronics housing 115 contains a: perineal sensing region 115a, comprised of the perineal accelerometer 114; bulk electronics region 115b. comprised of the processor 112, transceiver 111, control accelerometer 113; a spacer 115c. and a thin connector between 115alb. Separating most of the electronics from the perineal accelerometer into their own region maintains a small footprint at the anatomically narrow perineum (FIG. 3).

[0052] The electronics unit could be slipped into a two-layered, pocket-like placement pad 120, which functions to fixate the perineal movement detection device 110 to the correct location on the subject’ s / user’s undergarments relative to the subject / user, and as a san it ary barrier between the subject / user and the device 110. This pad has an anterior region 124, corresponding to the bulk region 115 > of the device 110, and posterior region 125, corresponding to the perineal region 115a of the device 110. An embodiment of this pad contains: an adhesive backing layer 121, used to attach the pad / device unit to the subject’ s / user's undergarment 126; and a sanitary7 layer 122 of the same shape, connected to the adhesive backing layer 121 along the layers’ perimeter excluding the anterior region 124 to reveal a pocket opening 123, through which the perineal movement detection device 110 is slipped in and sandwiched between the pad’s two layers. See FIGS. 3, 6, and 8.

[0053] As an alternative to placement pad 120, any suitable placement or positioning element could be used. Non-limiting examples include an adhesive element on the device's housing or on a removable sleeve that adheres directly onto the user's body, thus fixating the device in an anatomically relevant position. Other non-limiting examples include:

[0054] A. Designs featuring attachments to the user's own undergarment:

[0055] Al. adhesive pad that adheres directly onto the fabric of the undergarment; and

[0056] A2. element of the placement pad (or as part of the electronics housing itself) that wraps around the user's undergarment, thus fixating the device in an anatomically relevant position. This "wrapping" could be maintained with snaps, Velcro®, ties, buttons, buckles, clasps, or any other fastener that attaches the wrapping element back to the perineal activity detection device, housing, or placement pad.

[0057] B. Designs including specialized undergarment:

[0058] B 1. an undergarment made with a built-in pocket in an anatomically relevant position to input or remove the perineal activity detection device;

[0059] B2. an undergarment with the perineal activity detection electronics / hardware embedded in the fabric; and

[0060] B3. an undergarment / device fixation system where the device's placement pad (or the device's electronics housing itself) has a fixating element that attaches to a corresponding fixating element on the undergarment in an anatomically relevant position. This fixation system could involve snaps, Velcro®, ties, buttons, buckles, clasps, or any other fastener that attaches the undergarment to the perineal activity detection device, housing, or placement pad.

[0061] In an instruction manual, a subject / user could be instructed to slide the perineal movement detection device 110 into the placement pad 120, perineal sensing region 115« side first, line up the tip of the pad’s posterior region 125 with their perineum, and fixate the pad in that corresponding region of their underwear. This placement pad 120 is one example embodiment of a device placement method for the subject / user but, as previously indicated, could be replaced with any method that maintains contact between the perineal sensing region of the device 110 and the subject’ s / user’s perineum. See FIGS. 3, 6, and 8.

[0062] The computer device 130 (FIG. 7) comprises a transceiver 133, a memory 131, a processor 132, and an output device unit 134. The transceiver 133 is configured to transmit data to and receive data from the perineal movement detection device 110, and the output device unit 134 is configured to convey output data provided by the processor 132 to a subject / user of the computer device 130. The memory 131 can store system configuration programs, a data storage or bucket 131a configured to store data received from the perineal movement detection device 110 or generated by the computer device 130, and modules to process / act on this data.

[0063] The processor 132 is configured to monitor pelvic floor muscle activity of a subject / user who is using the perineal movement detection device 110, and to recognize pelvic floor contraction and release / strain of the subject / user throughout sessions of voluntary pelvic floor contractions. The processor 132 implements the functionality necessary to processes / act on / maintain items of received or generated data.

[0064] The computer device 130 can process orientation data generated by the perineal accelerometer 114 and control accelerometer 113 to generate an output that indicates if there has been a contraction or release / strain of the pelvic floor muscles during a measurement period. The calibrated orientation data and generated outputs from the processor can be displayed to the subject / user via the output device unit 134. An example of output signal data is shown in FIG. 5. Specifically, the bracket 30 shows the signal for one full Kegel discernable from background.

[0065] A data bucket 131a stores orientation data received from the perineal movement detection device 110 and data generated by actions performed by the computer device 130. An orientation determination module 131c is also provided that is configured to process the orientation data to determine a direction of rotation of the perineal movement detection device 110 during a measurement period and to generate an output indicating that there has been either a contraction or release of the pelvic floor muscles. The orientation data provided by the perineal accelerometer 114 and control accelerometer 113 will typically comprise a time series sequence of data points, with each data point defining the measured orientation of the perineal movement detection device at a particular point in time. The orientation / rotation determination module 131c could then be configured to determine a direction of rotation of the perineal movement detection device 110 when the change in the orientation of the perineal movement detection device during the measurement penod continues in the same direction for a predefined number of contiguous data points.

[0066] A calibration module 131 Z> can be implemented to generate parameters for calibrating the processing implemented by the system 100. To calibrate the orientation data for any noise that is present within the subject / user at rest, the perineal movement detection device 110 would be fixed in the proper location relative to the subject / user while the subject / user is instructed to remain still, and an anatomical calibration phase initiated. Upon initiation of the anatomical calibration phase, the calibration module 1316 w ould process data generated by the perineal accelerometer 114 and control accelerometer 113 to calculate values that are indicative of noise present within the subject / user at rest. These values can then be used by the orientation determination module 131c to eliminate noise due to the subject’s / user’s anatomy at rest from the orientation data generated during the measurement period. For example, the orientation determination module 131c could be configured to apply upper and lower thresholds to the accelerometer data generated during the measurement period.

[0067] A calibration can also be performed on the system 100 to account for noise that is present within the perineal movement detection device 110 itself. For this, before the perineal movement detection device 110 is positioned for use by the subject / user, the device would be held stationary, and an external calibration phase initiated. Upon initiation of the external calibration phase, the calibration module 131b would process data generated by the accelerometer 114 and control accelerometer 113 to calculate values that are indicative of noise present within the device. These values can then be used by the calibration module 131 / ? when performing the anatomical calibration of the subject / user.

[0068] An initiation detection module 13 k / can also be provided that is configured to detect the initiation of pelvic floor muscle movement and commence a measurement period. This module can be configured to detect the initiation of a pelvic floor muscle movement upon receiving a subject / user input indicating the initiation of a pelvic floor muscle movement. Alternatively, the initiation detection module 131rf can be configured to detect the initiation of a pelvic floor muscle movement by utilizing the orientation or acceleration data of the perineal accelerometer (on its own or in comparison to that of the control accelerometer 113 to detect significant movement of the perineal movement detection device 110 as an indication of pelvic floor muscle movement initiation.

[0069] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication w as specifically and individually indicated to be incorporated by reference. It is to be understood that while a certain form of the invention is illustrated, it is not intended to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification. One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The systems, methods, and / or devices described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention. Although the invention has been described in connection with specific, preferred embodiments, it should be understood that the invention as ultimately claimed should not be unduly limited to such specific embodiments. Indeed various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the invention.

[0070] References

[0071] U.S. Patent 10,925,487 B2

[0072] Kegel Exercises: A How-to Guide for Women; accessed from the website of the Mayo Clinic on August 18, 2023. Kegel exercises: A how-to guide for women - Mavo Clinic

[0073] U.S. Patent 11,324,999 B2

[0074] U.S. Patent 11,406,279 B2

Claims

The ClaimsWhat is claimed is:

1. A system for externally monitoring activity of a perineum of a subj ect during a contraction / release of pelvic floor muscles of the subject, the system comprising: a perineal movement detection device configured for external arrangement flush against the perineum of the subject; a computer device configured for communication with the perineal movement detection device; and a placement element for fixing the perineal movement detection device in an anatomically relevant position relative to the user during use of the system.

2. A system for externally monitoring movement of a perineum of a subject during a contraction / release of pelvic floor muscles of the subject, the system comprising: a perineal movement detection device configured for external arrangement flush against the perineum of the subject; a computer device configured for communication with the perineal movement detection device; and a placement pad configured for enclosing the perineal movement detection device and fixing the perineal movement detection device to a location on an undergarment of the subject such that position of the perineal movement detection device relative to the perineum of the subject is maintained during use of the system.

3. The system according to Claim 1 or Claim 2, wherein the perineal movement detection device and the computer device are configured for wireless communication.

4. The system according to Claim 1 or Claim 2, wherein the perineal movement detection device comprises at least one of a perineal accelerometer, a processor, a transceiver, and a control accelerometer.

5. The system according to Claim 1 or Claim 2, wherein the computer device comprises at least one of a transceiver, a memory, a processor, and a user display.

6. The system according to Claim 1 or Claim 2, wherein the perineal movement detection device comprises a housing, the housing including:an electronics region at a first end; a perineal sensing region at an end opposite the first end; and a connection strip configured as a spacer and a connection between the electronics region and the perineal sensing region.

7. The system according to Claim 2, wherein the perineal movement detection device comprises a housing, the housing including: an electronics region at a first end; a perineal sensing region at an end opposite the first end; and a connection strip configured as a spacer and a connection between the electronics region and the perineal sensing region; and wherein the placement pad comprises a first designed region corresponding to the electronics region of the housing, a second designated region corresponding to the perineal sensing region of the housing, and a connection strip corresponding to the connection strip of the housing.

8. The system according to Claim 7, wherein the placement pad further comprises an adhesive layer on one surface configured for fixing the perineal movement detection device to the location on the undergarment of the subject, a sanitary layer having a same shape as the adhesive layer and connected to the adhesive layer along a perimeter of the adhesive layer to form an interior space configured to enclose the perineal movement detection device between the adhesive layer and the sanitary layer, and an opening to the interior space at the first designated region configured for insertion of the perineal movement detection device.

9. The system according to Claim 4, wherein the perineal movement detection device includes a perineal accelerometer arranged in the perineal sensing region of the housing and configured for monitoring movement of the perineal sensing region.

10. The system according to Claim 9, wherein the perineal movement detection device includes a control accelerometer arranged in the electronics region of the housing, the control accelerometer configured for sensing non-perineal movements of the subject and for removing signals due to the non-perineal movements from the perineal accelerometer.

11. The system according to Claim 4, wherein the perineal movement detection device includes a processor and a transceiver arranged in the electronics region of the housing, thetransceiver configured to receive data from the computer device and to transmit data to the computer device.

12. The system according to Claim 2, wherein the placement pad fixes the perineal movement detection device to a location on the undergarment of the subject such that orientation of the perineal movement detection device relative to a sagittal axis of the perineum of the subject is maintained during use of the system.

13. The system according to Claim 1 or Claim 2, wherein the computer device comprises a transceiver, a processor, and a user display; wherein the transceiver is configured to transmit data to and receive data from the perineal movement detection device and the user display is configured to convey output data from the processor to the subject using the system.

14. The system according to Claim 13, wherein the computer device further comprises a memory and system configuration programs.

15. The system according to Claim 14, wherein the memory comprises a data bucket and at least one of a calibration module, an initiation detection module, and a movement detection module.

16. The system according to Claim 14, wherein the memory comprises: a calibration module configured for generating parameters for calibrating processing implemented by the system; an initiation detection module configured to detect initiation of pelvic floor muscle movement and to commence a measurement period; and a movement detection module configured to process orientation and / or other movement data to determine a direction of rotation of the perineal movement detection device during the measurement period and to generate an output indicating that there has been either a contraction or release of pelvic floor muscles of the subject.

17. The system according to Claim 13 or Claim 15, wherein the computer device further comprises a gaming app.

18. The system according to Claim 17, wherein the gaming app is based on non-invasive Kegel biofeedback.

19. A kit comprising a perineal movement detection device and a plurality of placement elements,20. The kit according to Claim 19. wherein the placement elements are placement pads.

21. The kit according to Claim 19 or Claim 20, further comprising a computer device.

22. A method for externally monitoring activity of a perineum of a subject during a contraction / release of pelvic floor muscles of the subject, the method comprising: coupling a perineal movement detection device with a placement element; fixing the perineal movement detection device with the placement element in an anatomically relevant position relative to the user that is maintained during use; monitoring the activity of the perineum during the series of voluntary pelvic floor contractions; and processing activity thereby generating an output signal indicating if there has been a contraction or release of the pelvic floor muscles during the measurement period.

23. The method of Claim 22, wherein monitoring activity comprises at least one of monitoring movement of the perineum and monitoring orientation of the perineum.

24. The method of Claim 23. wherein the placement element is a placement pad and the method further comprises: inserting the perineal movement detection device into the placement pad such that the perineal movement detection is enclosed in an interior of the placement pad; and attaching the placement pad to an undergarment such that a designated region of the placement pad corresponds to a perineal sensing region of the perineal movement detection device.

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