Disposable Stress Urinary Incontinence Pessary Device Study

• ClinicalTrials.gov Identifier: NCT03323723
• Recruitment Status: Completed
• First Posted: October 27, 2017
• Results First Posted: May 16, 2019
• Last Update Posted: May 16, 2019
• Sponsor: Rinovum Women's Health, Inc.
• Information provided by (Responsible Party): Rinovum Women's Health, Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stress Urinary Incontinence
• Intervention: Device: SUI Device
• Enrollment: 73

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	RS-2 SUI Device
Arm/Group Description	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.
Period Title: Screening
Started	73
Completed	64
Not Completed	9
Period Title: Baseline Phase
Started	64
Completed	60
Not Completed	4
Period Title: Treatment Phase
Started	60
Completed	51
Not Completed	9

Baseline Characteristics

Arm/Group Title		RS-2 SUI Device
Arm/Group Description		Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
Overall Number of Baseline Participants		73
Baseline Analysis Population Description		Analysis conducted on mITT population.
Age, Customized [1]; Mean (Standard Deviation); Unit of measure: Years
Average Age	Number Analyzed	48 participants
		53.4 (12.04)
		[1] Measure Analysis Population Description: All analyses performed on mITT population.
Sex/Gender, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Sex, Female	Number Analyzed	73 participants
		73 100.0%
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants
	Hispanic or Latino	5 10.4%
	Not Hispanic or Latino	43 89.6%
	Unknown or Not Reported	0 0.0%
		[1] Measure Analysis Population Description: All analyses performed on mITT population.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	73 participants
		73 100.0%

Outcome Measures

1. Primary Outcome

Title	Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.
Description	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).
Time Frame	7 days of the baseline phase and 7 days of treatment phase

Outcome Measure Data

Analysis Population Description

mITT Population

Arm/Group Title	RS-2 SUI Device
Arm/Group Description:	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.
Overall Number of Participants Analyzed	48
Mean (98.33% Confidence Interval); Unit of Measure: percent change
	-47.4; (-61.13 to -33.76)

2. Secondary Outcome

Title	Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase
Description	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.
Time Frame	7 days of baseline period and last 7 days of treatment phase

Outcome Measure Data

Analysis Population Description

mITT population

Arm/Group Title	RS-2 SUI Device
Arm/Group Description:	Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
Overall Number of Participants Analyzed	48
Mean (95% Confidence Interval); Unit of Measure: number of episodes
	-1.00; (-1.37 to -0.75)

3. Secondary Outcome

Title	Change in Quality of Life From Before Treatment Phase to After Treatment Phase
Description	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).
Time Frame	Before Treatment Phase and After Treatment Phase is complete

Outcome Measure Data

Analysis Population Description

mITT population

Arm/Group Title	RS-2 SUI Device
Arm/Group Description:	Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
Overall Number of Participants Analyzed	48
Mean (95% Confidence Interval); Unit of Measure: Change in QoL score
	-4.35; (-6.22 to -2.49)

4. Secondary Outcome

Title	Adverse Events and Labs Evaluation to Determine Safety of the Device
Description	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.
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	RS-2 SUI Device
Arm/Group Description:	Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
Overall Number of Participants Analyzed	73
Measure Type: Number; Unit of Measure: events
Adverse Events	40
Abnormal Laboratory Findings	3

Adverse Events

Time Frame	Through study completion, an average of 21 days.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	RS-2 SUI Device
Arm/Group Description	Comparing use of device to non-treatment phase SUI Device: Pessary SUI device
All-Cause Mortality
	RS-2 SUI Device
	Affected / at Risk (%)
Total	0/73 (0.00%)
Serious Adverse Events
	RS-2 SUI Device
	Affected / at Risk (%)	# Events
Total	0/73 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	RS-2 SUI Device
	Affected / at Risk (%)	# Events
Total	22/73 (30.14%)
General disorders
General Disorders and Administration Site Conidtions - Other, Specify †	1/73 (1.37%)	1
Infections and infestations
Urinary Tract Infection †	1/73 (1.37%)	1
Musculoskeletal and connective tissue disorders
Back Pain †	1/73 (1.37%)	1
Renal and urinary disorders
Renal and Urinary Disorders - Other, Specify (Asymptomatic Bacteruria) †	1/73 (1.37%)	1
Renal and Urinary Disorders - Other, Specify (Nocturia) †	1/73 (1.37%)	1
Urinary Frequency †	1/73 (1.37%)	1
Urinary Incontinence †	2/73 (2.74%)	2
Urinary Retention †	2/73 (2.74%)	2
Reproductive system and breast disorders
Genital Edema †	1/73 (1.37%)	1
Pelvic Pain †	1/73 (1.37%)	1
Uterine Pain †	4/73 (5.48%)	4
Vaginal Discharge †	2/73 (2.74%)	2
Vaginal Dryness †	1/73 (1.37%)	1
Vaginal Hemorrhage (Spotting) †	4/73 (5.48%)	4
Vaginal Pain †	6/73 (8.22%)	14
Skin and subcutaneous tissue disorders
Pain of Skin †	3/73 (4.11%)	3
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Clinical Development Manager
• Organization: Rinovum Subsidiary 2, LLC.
• Phone: 7242418932
• EMail: hwhitelam@rinovum.com

• Responsible Party: Rinovum Women's Health, Inc.
• ClinicalTrials.gov Identifier: NCT03323723
• Other Study ID Numbers: TP-00002
• First Submitted: October 13, 2017
• First Posted: October 27, 2017
• Results First Submitted: March 25, 2019
• Results First Posted: May 16, 2019
• Last Update Posted: May 16, 2019