Trial Outcomes & Findings for Disposable Stress Urinary Incontinence Pessary Device Study (NCT NCT03323723)

Last Updated: 2019-05-16

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

7 days of the baseline phase and 7 days of treatment phase

Results posted on

2019-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	RS-2 SUI Device All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
Screening STARTED	73
Screening COMPLETED	64
Screening NOT COMPLETED	9
Baseline Phase STARTED	64
Baseline Phase COMPLETED	60
Baseline Phase NOT COMPLETED	4
Treatment Phase STARTED	60
Treatment Phase COMPLETED	51
Treatment Phase NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All analyses performed on mITT population.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RS-2 SUI Device n=73 Participants Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
Age, Customized Average Age	53.4 years STANDARD_DEVIATION 12.04 • n=48 Participants • All analyses performed on mITT population.
Sex/Gender, Customized Sex, Female	73 Participants n=73 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=48 Participants • All analyses performed on mITT population.
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=48 Participants • All analyses performed on mITT population.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=48 Participants • All analyses performed on mITT population.
Region of Enrollment United States	73 Participants n=73 Participants

PRIMARY outcome

Timeframe: 7 days of the baseline phase and 7 days of treatment phase

Population: mITT Population

Outcome measures

Outcome measures
Measure	RS-2 SUI Device n=48 Participants All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.	-47.4 percent change Interval -61.13 to -33.76

SECONDARY outcome

Timeframe: 7 days of baseline period and last 7 days of treatment phase

Population: mITT population

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.

Outcome measures

Outcome measures
Measure	RS-2 SUI Device n=48 Participants All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase	-1.00 number of episodes Interval -1.37 to -0.75

SECONDARY outcome

Timeframe: Before Treatment Phase and After Treatment Phase is complete

Population: mITT population

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).

Outcome measures

Outcome measures
Measure	RS-2 SUI Device n=48 Participants All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
Change in Quality of Life From Before Treatment Phase to After Treatment Phase	-4.35 Change in QoL score Interval -6.22 to -2.49

SECONDARY outcome

Timeframe: 21 days

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	RS-2 SUI Device n=73 Participants All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device.
Adverse Events and Labs Evaluation to Determine Safety of the Device Adverse Events	40 events
Adverse Events and Labs Evaluation to Determine Safety of the Device Abnormal Laboratory Findings	3 events

Adverse Events

RS-2 SUI Device

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RS-2 SUI Device n=73 participants at risk Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
General disorders General Disorders and Administration Site Conidtions - Other, Specify	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Infections and infestations Urinary Tract Infection	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Musculoskeletal and connective tissue disorders Back Pain	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Renal and urinary disorders Renal and Urinary Disorders - Other, Specify (Asymptomatic Bacteruria)	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Renal and urinary disorders Renal and Urinary Disorders - Other, Specify (Nocturia)	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Renal and urinary disorders Urinary Frequency	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Renal and urinary disorders Urinary Incontinence	2.7% 2/73 • Number of events 2 • Through study completion, an average of 21 days.
Renal and urinary disorders Urinary Retention	2.7% 2/73 • Number of events 2 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Genital Edema	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Pelvic Pain	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Uterine Pain	5.5% 4/73 • Number of events 4 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Vaginal Discharge	2.7% 2/73 • Number of events 2 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Vaginal Dryness	1.4% 1/73 • Number of events 1 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Vaginal Hemorrhage (Spotting)	5.5% 4/73 • Number of events 4 • Through study completion, an average of 21 days.
Reproductive system and breast disorders Vaginal Pain	8.2% 6/73 • Number of events 14 • Through study completion, an average of 21 days.
Skin and subcutaneous tissue disorders Pain of Skin	4.1% 3/73 • Number of events 3 • Through study completion, an average of 21 days.

Additional Information

Clinical Development Manager

Rinovum Subsidiary 2, LLC.

Phone: 7242418932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research results and associated data will be considered confidential until the earlier of: (i) the first publication or presentation thereof data according to the terms of this agreement; (ii) one (1) year after conclusion, abandonment, or termination of the Research at all sites.
Publication restrictions are in place

Restriction type: OTHER