Pelvic Floor Muscle Training With Leva System for Urge Incontinence

Study Overview
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Brief Summary
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This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.

Detailed Description
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Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined.

Official Title
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Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study

Conditions
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Overactive Bladder, Urge Urinary Incontinence, Mixed Urinary Incontinence

Intervention / Treatment
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* Device: Leva device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85 years old Urinary incontinence for ≥ 3 months Reporting at least moderate bother on Item 2 on the UDI-6, Do you experience urine leakage in related to the feeling of urgency (on new patient paperwork) If mixed urinary incontinence, Medical Epidemiologic Social Aspect of Aging Urinary Incontinence Questionnaire (MESA) score indicating urge-predominant MUI (Urge subscale % > Stress subscale %) Presence of ≥ 1 UUI episode on 3-d bladder diary (see Appendix 2) Is the baseline bladder diary consistent with the patient's typical habits? Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2 week wash-out period) Brink Score > 3 (see below) Access to smartphone technology, including iOS or Android™ Exclusion Criteria: Non-English speakers Severely impaired mobility or cognition Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease Concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months Received intravesical botulinum injection within the previous 12 months History of implanted nerve stimulator for incontinence History of prior sling or vaginal mesh placement Previous diagnosis of Interstitial cystitis Active pelvic organ malignancy History of pelvic radiation Urethral obstruction Urinary retention or prolonged catheter use Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months Untreated symptomatic urinary tract infection Unevaluated hematuria Medical instability Not available for follow-up in 6 months Participation in other research trials that could influence results of this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Interventional Model Description: Non-blinded non-comparative pilot trial in which subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leva Users<br>Subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks. | Device: Leva device<br>* The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urogenital Distress Inventory | The Urogenital Distress Inventory (UDI) is a 19-item questionnaire assessing subjective symptoms of pelvic floor disorders including incontinence. The 19 items fall into one of three subscales (Irritative symptoms, Obstructive symptoms, and Stress Symptoms). . The subject responds to each item by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. For scoring, first each subscale score is calculated by finding the mean score of items within the subscale section, subtracting 1, and multiplying that by 100/3. Next, the subscale scores are summed to determine the overall UDI score with possible scores ranging from 0-300. High scores indicate greater symptoms severity. | Change from Baseline UDI score to 8 weeks and 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence Impact Questionnaire Short Form (IIQ-7) | Validated short-form version of the Incontinence Impact Questionnaire used to describe incontinence-related quality of life. It consists of 7 items assessing four general areas including travel, social, emotional, and physical activities. For each item, the subject responds by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. Scores are generated by finding the mean score for each item and multiplying that by 100/3. Higher scores indicate greater negative impact on quality of life. | Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention | 
| Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary | A voiding diary is considered standard of care in the work-up of a patient with incontinence to better characterize real-life drinking and voiding habits. The number of urge urinary incontinence episodes is determined by adding up the incontinence episodes recorded by the patient that were associated with an urge to get to the bathroom. More incontinence episodes means a greater severity of incontinence | Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female urinary incontinence, urge urinary incontinence, urgency, frequency, overactive bladder, pelvic floor muscle training, biofeedback