Disposable Stress Urinary Incontinence Pessary Device Study

• Sponsor: Rinovum Women's Health, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03323723
• Collaborator: (none)
• Enrollment: 73
• Locations: 3
• Arm: 1
• Actual Duration (Months): 6.5
• Patients Per Site: 24.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: SUI Device	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Efficacy and Safety Study, Single Group, Open Study, Open LabelEfficacy and Safety Study, Single Group, Open Study, Open Label
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study
• Actual Study Start Date: Oct 16, 2017
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: RS-2 SUI Device Comparing use of device to non-treatment phase	Device: SUI Device; Pessary SUI device

Outcome Measures

Primary Outcome Measures

1. Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase. [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).

Secondary Outcome Measures

1. Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase [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.

2. Change in Quality of Life From Before Treatment Phase to After Treatment Phase [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).

3. Adverse Events and Labs Evaluation to Determine Safety of the Device [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195
2	Allegheny Health Network/East Suburban OB/GYN	Monroeville	Pennsylvania	United States	15146
3	West Virginia University Medicine	Morgantown	West Virginia	United States	26501

Sponsors and Collaborators

• Rinovum Women's Health, Inc.

Investigators

• Principal Investigator: Omar Felipe Duenas Garcia, MD, West Virginia University Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 3, 2017

More Information

Publications

None provided.

• Responsible Party: Rinovum Women's Health, Inc.
• ClinicalTrials.gov Identifier: NCT03323723
• Other Study ID Numbers: TP-00002
• First Posted: Oct 27, 2017
• Last Update Posted: May 16, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

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: Screening
STARTED	64
COMPLETED	60
NOT COMPLETED	4
Period Title: Screening
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 Participants	73
Age, Customized (years) [Mean (Standard Deviation) ]
Average Age	53.4 (12.04)
Sex/Gender, Customized (Count of Participants)
Sex, Female	73 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 6.8%
Not Hispanic or Latino	43 58.9%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	73 100%

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.
Measure Participants	48
Mean (98.33% Confidence Interval) [percent change]	-47.4

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
Measure Participants	48
Mean (95% Confidence Interval) [number of episodes]	-1.00

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
Measure Participants	48
Mean (95% Confidence Interval) [Change in QoL score]	-4.35

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
Measure Participants	73
Adverse Events	40
Abnormal Laboratory Findings	3

Adverse Events

Time Frame	Through study completion, an average of 21 days.
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 (%)	# Events
Total	0/73 (0%)
Serious Adverse Events
	RS-2 SUI Device
	Affected / at Risk (%)	# Events
Total	0/73 (0%)
Other (Not Including Serious) Adverse Events
	RS-2 SUI Device
	Affected / at Risk (%)	# Events
Total	22/73 (30.1%)
General disorders
General Disorders and Administration Site Conidtions - Other, Specify	1/73 (1.4%)	1
Infections and infestations
Urinary Tract Infection	1/73 (1.4%)	1
Musculoskeletal and connective tissue disorders
Back Pain	1/73 (1.4%)	1
Renal and urinary disorders
Renal and Urinary Disorders - Other, Specify (Asymptomatic Bacteruria)	1/73 (1.4%)	1
Renal and Urinary Disorders - Other, Specify (Nocturia)	1/73 (1.4%)	1
Urinary Frequency	1/73 (1.4%)	1
Urinary Incontinence	2/73 (2.7%)	2
Urinary Retention	2/73 (2.7%)	2
Reproductive system and breast disorders
Genital Edema	1/73 (1.4%)	1
Pelvic Pain	1/73 (1.4%)	1
Uterine Pain	4/73 (5.5%)	4
Vaginal Discharge	2/73 (2.7%)	2
Vaginal Dryness	1/73 (1.4%)	1
Vaginal Hemorrhage (Spotting)	4/73 (5.5%)	4
Vaginal Pain	6/73 (8.2%)	14
Skin and subcutaneous tissue disorders
Pain of Skin	3/73 (4.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.