A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

February 23, 2016 updated by: Procter and Gamble
This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • have a ≥ 3 month history of experiencing Stress Urinary Incontinence
  • be willing to use the pessary investigational device to control stress incontinence

Exclusion Criteria:

  • pregnant, lactating or planning to become pregnant during the study
  • within 3 months post partum
  • intrauterine device (IUD) placement of less than 6 months
  • a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS
  • experience difficulty inserting or wearing an intra-vaginal device, including a tampon
  • 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
  • for any reason, the Investigator decides that the subject should not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pessary device
pessary (disposable intra-vaginal device)
Device: pessary (disposable intra-vaginal device)
pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pad Weight Gain
Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
from the 14-day baseline period to the last 7 days of 14-day device usage period
Change in Stress Urinary Incontinence Episodes
Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
from the 14-day baseline period to the last 7 days of 14-day device usage period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
Time Frame: baseline and end-of-treatment
The IIQ-7 is based on 7 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, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 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.
baseline and end-of-treatment
Change in Pad Weight Gain
Time Frame: from the 14-day baseline period to the first 7 days of 14-day device usage period
Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
from the 14-day baseline period to the first 7 days of 14-day device usage period
Change in Stress Urinary Incontinence Episodes
Time Frame: from the 14-day baseline period to the first 7 days of 14-day device usage period
Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
from the 14-day baseline period to the first 7 days of 14-day device usage period

Other Outcome Measures

Outcome Measure
Time Frame
Percentage of Responders for Pad Weight Gain
Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
from the 14-day baseline period to the last 7 days of 14-day device usage period
Percentage of Responders for SUI Episodes
Time Frame: from the 14-day baseline period to the last 7 days of 14-day device usage period
from the 14-day baseline period to the last 7 days of 14-day device usage period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Principal Investigator: Randall Severance, MD, Radiant Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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