Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence

Study Overview
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Brief Summary
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A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.

Detailed Description
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A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.

Official Title
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A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence

Conditions
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Stress Urinary Incontinence, Mixed Urinary Incontinence

Intervention / Treatment
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* Device: Leva
* Device: PFDx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving informed consent. Self-reported stress-type UI symptoms of >= three months duration Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score). UDI-6 score >/= 25 Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks. Exclusion Criteria: Absence of a vagina. Age <18 years. Stage 3-4 pelvic organ prolapse (as determined by POP-Q). Diagnosis of any neuromuscular disease. Non-ambulatory. Currently pregnant or <12 months post-partum. </= 3 months after failed surgery for stress urinary incontinence. Previous pelvic floor muscle training (PFMT) within the last 12 months under a supervised therapeutic plan of care. Currently taking, or has taken within the last 2 months, medication to treat urinary incontinence. Prior augmentation cystoplasty or artificial sphincter. Implanted nerve stimulator for urinary symptoms. Participation in another clinical study within 30 days of screening. Impaired cognitive function. Contraindication to the use of a vaginal probe. Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health System. Unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leva Arm<br>Subjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months. | Device: Leva<br>* Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.<br>Device: PFDx<br>* All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.<br>|
| Active Comparator: Kegel Arm<br>Subjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. | Device: PFDx<br>* All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGI-I | PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. | 8 weeks after randomization | 
| UDI-6 | Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms | 8 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-day voiding diary | An objective evaluation of urinary incontinence | 8 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Health, Female