IRIS: Incontinence Research Intervention Study

November 9, 2010 updated by: University of Michigan

Office for Research on Women's Health (ORWH): Specialized Centers of Research (SCOR) on Sex and Gender Factors Affecting Women's Health. Project 3: Selection Criteria For Muscle Therapy in SUI

The IRIS project stands for Incontinence Research Intervention Study. The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy, a self-help treatment. The Knack therapy involves learning the skill of performing a pelvic muscle contraction simultaneously with an event known to trigger leakage, in order to stop that leakage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This proposal aims to develop and test, in a general population of women with stress urinary incontinence (SUI), a model for predicting who will succeed in overcoming incontinence long-term (1-year) by simply using Knack therapy (thus avoiding invasive and costly surgery and time consuming Kegel's exercises). Specific Aims are to:

  • develop a logistic regression model to predict success with the Knack;
  • validate the model by determining the proportion of people who succeed according to who is predicted to succeed; and
  • develop long-term effectiveness of the Knack (1-year).

The project will be implemented in three phases: model development (n=160 women), model validation (n~160), and long-term follow-up of women who demonstrate response. This will be evaluated immediately and at 1 month and at 3-months and 1-year.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 2
  • Phase 1

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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, School of Nursing

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:

  • Women who are incontinent
  • Women who experience leakage with coughing, sneezing or exercising
  • Women who are generally healthy
  • Women who are over the age of eighteen
  • Women who are not pregnant nor expecting to become pregnant within a year

Exclusion Criteria:

  • No urine leakage when coughing, sneezing, or exercising
  • Under the age of eighteen
  • Pregnant or expecting to become pregnant
  • Untreated urinary tract infection
  • Pronounced pain or discomfort with pelvic exams
  • History of neurologic conditions

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The short-term outcome of "positive response" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately at 1 month.

Secondary Outcome Measures

Outcome Measure
Long-term success (3-months and 1-year) is defined both by the paper towel test criteria and by documentation of at least 50% reduction of leakage in diary to reflect success at home.

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Janis M Miller, PhD, APRN, University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology
  • Study Director: John OL DeLancey, MD, University of Michigan, Obstetrics & Gynecology

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

January 1, 2003

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 27, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

July 29, 2005

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50HD044406 (U.S. NIH Grant/Contract)
  • 1P50HD044406 (U.S. NIH Grant/Contract)
  • IRBMED# 2002-0635 (Other Identifier: University of Michigan IRB)

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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