A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

Study Overview
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Brief Summary
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This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).

Official Title
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A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: pessary (disposable intra-vaginal device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a ≥ 3 month history of experiencing Stress Urinary Incontinence be willing to use the pessary investigational device to control stress incontinence Exclusion Criteria: pregnant, lactating or planning to become pregnant during the study within 3 months post partum intrauterine device (IUD) placement of less than 6 months a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS experience difficulty inserting or wearing an intra-vaginal device, including a tampon vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator for any reason, the Investigator decides that the subject should not participate in the study

Ages Eligible for Study
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Minimum Age: 18 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: pessary device<br>pessary (disposable intra-vaginal device) | Device: pessary (disposable intra-vaginal device)<br>* pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pad Weight Gain | Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. | from the 14-day baseline period to the last 7 days of 14-day device usage period | 
| Change in Stress Urinary Incontinence Episodes | Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome. | from the 14-day baseline period to the last 7 days of 14-day device usage period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pad Weight Gain | Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. | from the 14-day baseline period to the first 7 days of 14-day device usage period | 
| Change in Stress Urinary Incontinence Episodes | Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome. | from the 14-day baseline period to the first 7 days of 14-day device usage period | 
| Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) | The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life. | baseline and end-of-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUI, Stress urinary incontinence