IRIS: Incontinence Research Intervention Study

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence; Urinary Incontinence, Stress	Behavioral: Knack therapy	Phase 1; Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	320 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	January 2003
Actual Study Completion Date :	April 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Michigan

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00125177 History of Changes
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 )
First Posted:	July 29, 2005
Last Update Posted:	November 10, 2010
Last Verified:	July 2005

Keywords provided by University of Michigan:

pelvic muscle therapy; urinary incontinence therapy; stress incontinence intervention; incontinence intervention	Incontinence; SUI; Stress Incontinence

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms	Urological Manifestations; Signs and Symptoms; Behavioral Symptoms; Elimination Disorders; Mental Disorders