Disposable Stress Urinary Incontinence Pessary Device Study

Study Overview
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Brief Summary
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This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.

Detailed Description
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The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.

Official Title
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Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: SUI Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Provision of signed and dated informed consent form Literacy must be in English (able to read and understand Informed Consent) Stated willingness to comply with all study procedures and availability for the duration of the study Female, aged >18 Be in generally good heath as determined by the Investigator Have a physician diagnosis of SUI that occurred prior to or during the screening visit of this study Have a > 3-month history of experiencing > 3 episodes of SUI per week Be willing to use the investigational pessary device for the control of urinary incontinence Have experience with wearing a tampon The most recent Pap smear is normal within 36 months. Exclusion Criteria: • Is pregnant, or planning to become pregnant during the study Has been physician diagnosed with urge urinary incontinence or mixed urinary incontinence prior to or during the screening visit for this study Is post-partum within 3 months Has had an intrauterine device (IUD) placement of less than 6 months Has self-reported difficulty emptying her bladder; Has a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS; Has experienced difficulty inserting or wearing an intra-vaginal device, including a tampon; Has had 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 participant or the outcome of the study Has an active urinary tract infection or vaginal infection requiring treatment If for any reason, the Investigator decides that the participant should not participate in the study. Class III Obesity (BMI> 40.0 kg/m2) Advanced prolapse Fit assessment is not successful during screening visit

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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Accepts Healthy Volunteers

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: Efficacy and Safety Study, Single Group, Open Study, Open Label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RS-2 SUI Device<br>Comparing use of device to non-treatment phase | Device: SUI Device<br>* Pessary SUI device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase. | Pad weight gain (PWG) was measured by weighing used pads returned by participants and subtracting the pre-weight of that pad to obtain the total weight of leakage. The total weight of leakage was then divided by the number of hours the pad was worn by the participant to calculate the PWG/hr. The average PWG/hr for baseline was calculated by averaging the PWG/hr for the entire 7 days of the baseline phase. The average treatment PWG/hr for treatment phase was calculated by averaging the PWG/hr of the last 7 days of treatment phase. The percent change from baseline to treatment phase was then calculated. The objective was to show that PWG/hr is reduced by >50% during treatment phase. Thus, the null hypothesis is that the mean weight gain reduction per hour is <=50%, and the alternative is that it is >50%, from the control period (no device) to the treatment period (women wearing the device). | 7 days of the baseline phase and 7 days of treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase | Change in mean number of SUI episodes per day from the 7-day baseline period to the last 7 days of the 14-day device treatment period. Participants will record SUI episodes in the Study Diary during the baseline (7 days) and treatment (14 days) periods. Negative values are indicative of efficacious outcome. Each subject will have a change in the number of episodes per day from the control period to the treatment period. Specifically, the number of episodes will be recorded each day in the diary. For the control phase, there will be (at most) 7 days of data. The mean number of SUI episodes per day will be computed for each subject. The same measures will occur in the treatment period for the analysis period, the last 7 days. | 7 days of baseline period and last 7 days of treatment phase | 
| Change in Quality of Life From Before Treatment Phase to After Treatment Phase | Change in Quality of Life as measured by the ICIQ-LUTSqol - The Quality of Life Questionnaire to be performed at baseline, before, and after treatment phase of the study is based on 20 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, 1 = 'Not at all,' 2= 'Slightly,' 3 = 'Moderately,' or 4 'A lot.' Each area is then assessed on a scale of 1-10 to see how much it bothers them. The Questionnaire is scored by taking the average score of items and then multiplying that value by 25 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 at the end of the Treatment Phase from post-baseline/before Treatment Phase, reflects improved quality of life. A reduction in score of > 3.7 is considered the Minimum Clinically Important Difference (MCID). | Before Treatment Phase and After Treatment Phase is complete | 
| Adverse Events and Labs Evaluation to Determine Safety of the Device | Evaluation and analysis of AEs to determine safety as recommended in FDA SUI Clinical Trial Guidance - The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination. | 21 days |