A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

January 15, 2016 updated by: Procter and Gamble
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

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:

  • be female 18 years or older;
  • provide written informed consent prior to study participation and been given a signed copy;
  • be in generally good health as determined by the Investigator;
  • have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
  • be willing to use the pessary investigational device to control stress urinary incontinence;
  • be willing to comply with study requirements and instructions;

Exclusion Criteria:

  • are pregnant, lactating, or planning to become pregnant during the study;
  • within 3 months post partum;
  • intrauterine device (IUD) placement of less than 6 months;
  • has self-reported difficulty emptying her bladder;
  • 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 and could impact the safety of the subject or the outcome of the study; or
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pessary
disposable, single-use pessary
Device: pessary
disposable, single-use pessary
Placebo Comparator: pad
absorbent pad control
Device: Absorbent pad
Other Names:
  • placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent Serious Adverse Event
Time Frame: 3 month
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
3 month

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

May 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012119

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.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on Absorbent pad

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe