Use of the Leva Incontinence System in Treating Bladder Incontinence.

Study Overview
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Brief Summary
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This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Official Title
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Use of the Leva Incontinence System in Treating Bladder Incontinence.

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Leva Incontinence System For Pelvic Floor Muscle strengthening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must be female. Subjects must be capable of giving informed consent. Subjects should be at least 18 years of age and less than 89 years of age Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys. Exclusion Criteria: Absence of a vagina. Positive drug or alcohol test at the screening visit. Post-menopausal defined as absence of a period for over 12 months. Pregnancy or being less than 12 months post-partum. Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure). Symptoms of stage II or greater pelvic organ prolapse. BMI >31 kg/m2. Diagnosis of any neurological disorder. Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI). Prior pelvic radiation. Current or recurrent vaginal infections (>three per year). Painful bladder syndrome, active or chronic pelvic pain. Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care. Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder. Currently taking medication to treat incontinence. Impaired cognitive function. Unable to tolerate use of the leva device.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leva Arm<br>Subjects will use the leva device twice daily to perform pelvic floor muscle exercises | Device: Leva Incontinence System For Pelvic Floor Muscle strengthening<br>* The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Urinary Incontinence at Baseline and at 6 Weeks | A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. | Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement. | 6 weeks | 
| Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) | Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree). | At 6 weeks | 
| Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) | Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can hold the lift was recorded | 6 weeks | 

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