A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.

Official Title
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A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence (SUI)

Intervention / Treatment
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* Device: disposable, single-use pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be female 18 years or older; provide written informed consent prior to study participation and receive a signed copy; be in generally good health as determined by the Investigator; have a ≥ 3 month history of experiencing SUI (self reported); be willing to use the pessary investigational device to control stress urinary incontinence; be willing to comply with study requirements and instructions; 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; has self-reported difficulty emptying her bladder; 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 which could impact the safety of the subject or the outcome of the study; 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<br>disposable, single-use pessary | Device: disposable, single-use pessary<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders for Pad Weight Gain or SUI Episodes |  | 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 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 | 
| 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 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 | 
| 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 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 a 14-day device usage period | 
| Percentage of Responders for Pad Weight Gain or SUI Episodes |  | from the 14-day baseline period to the first 7 days of 14-day device usage period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single use, disposable, pessary, stress urinary incontinence, sui