Disposable Stress Urinary Incontinence Pessary Device Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03323723|
Recruitment Status : Completed
First Posted : October 27, 2017
Results First Posted : May 16, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Device: SUI Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Efficacy and Safety Study, Single Group, Open Study, Open Label|
|Masking:||None (Open Label)|
|Official Title:||Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study|
|Actual Study Start Date :||October 16, 2017|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 1, 2018|
RS-2 SUI Device
Comparing use of device to non-treatment phase
Device: SUI Device
Pessary SUI device
- Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase. [ Time Frame: 7 days of the baseline phase and 7 days of treatment 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).
- Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase [ Time Frame: 7 days of baseline period and last 7 days of treatment 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.
- Change in Quality of Life From Before Treatment Phase to After Treatment Phase [ Time Frame: Before Treatment Phase and After Treatment Phase is complete ]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).
- Adverse Events and Labs Evaluation to Determine Safety of the Device [ Time Frame: 21 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323723
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Allegheny Health Network/East Suburban OB/GYN|
|Monroeville, Pennsylvania, United States, 15146|
|United States, West Virginia|
|West Virginia University Medicine|
|Morgantown, West Virginia, United States, 26501|
|Principal Investigator:||Omar Felipe Duenas Garcia, MD||West Virginia University Medicine|