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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.

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE October 27, 2017
Results First Submitted Date  ICMJE March 25, 2019
Results First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE October 16, 2017
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase. [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
Mean pad weight gain reduction of >50% when comparing the pad weight gain baseline phase as compared to the treatment phase [ Time Frame: 21 days ]
Mean pad weight gain reduction is >50% during the last 7 days of the treatment phase as compared to the baseline phase. The objective is to show that reduction in the mean pad weight gain per hour is >50% in the treatment period. 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase [ Time Frame: 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.
  • Change in Quality of Life From Before Treatment Phase to After Treatment Phase [ Time Frame: 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).
  • Adverse Events and Labs Evaluation to Determine Safety of the Device [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
  • Reduction in Mean SUI episodes during treatment phase as compared to baseline phase [ Time Frame: 21 days ]
    Reduction 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.
  • Quality of Life - Measured improvement during treatment phase [ Time Frame: 21 days ]
    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 from baseline 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 [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disposable Stress Urinary Incontinence Pessary Device Study
Official Title  ICMJE Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Efficacy and Safety Study, Single Group, Open Study, Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE Device: SUI Device
Pessary SUI device
Study Arms  ICMJE RS-2 SUI Device
Comparing use of device to non-treatment phase
Intervention: Device: SUI Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
73
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2017)
60
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03323723
Other Study ID Numbers  ICMJE TP-00002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rinovum Women's Health, Inc.
Study Sponsor  ICMJE Rinovum Women's Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omar Felipe Duenas Garcia, MD West Virginia University Medicine
PRS Account Rinovum Women's Health, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP