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Disposable Stress Urinary Incontinence Pessary Device Study

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SUI Device
Sponsored by
Rinovum Women's Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic
  • Allegheny Health Network/East Suburban OB/GYN
  • West Virginia University Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RS-2 SUI Device

Arm Description

Comparing use of device to non-treatment phase

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 13, 2017
Last Updated
May 14, 2019
Sponsor
Rinovum Women's Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03323723
Brief Title
Disposable Stress Urinary Incontinence Pessary Device Study
Official Title
Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rinovum Women's Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Efficacy and Safety Study, Single Group, Open Study, Open Label
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RS-2 SUI Device
Arm Type
Other
Arm Description
Comparing use of device to non-treatment phase
Intervention Type
Device
Intervention Name(s)
SUI Device
Intervention Description
Pessary SUI device
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Felipe Duenas Garcia, MD
Organizational Affiliation
West Virginia University Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Allegheny Health Network/East Suburban OB/GYN
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
West Virginia University Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32453209
Citation
Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.
Results Reference
derived

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Disposable Stress Urinary Incontinence Pessary Device Study

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