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Trial record 1 of 4 for:    rinovum
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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
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RS-2 SUI Device
Hide 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
Arm/Group Title RS-2 SUI Device
Hide Arm/Group Description

Comparing use of device to non-treatment phase

SUI Device: Pessary SUI device

Overall Number of Baseline Participants 73
Hide 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%
1.Primary Outcome
Title Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title RS-2 SUI Device
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title RS-2 SUI Device
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title RS-2 SUI Device
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title RS-2 SUI Device
Hide 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
Time Frame Through study completion, an average of 21 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RS-2 SUI Device
Hide 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%)    
Hide Serious Adverse Events
RS-2 SUI Device
Affected / at Risk (%) # Events
Total   0/73 (0.00%)    
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Clinical Development Manager
Organization: Rinovum Subsidiary 2, LLC.
Phone: 7242418932
EMail: hwhitelam@rinovum.com
Layout table for additonal information
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