IRIS: Incontinence Research Intervention 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. Identifier: NCT00125177
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : November 10, 2010
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Michigan

July 27, 2005
July 29, 2005
November 10, 2010
January 2003
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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.
Same as current
Complete list of historical versions of study NCT00125177 on Archive Site
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.
Same as current
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IRIS: Incontinence Research Intervention Study
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.

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.

Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Urinary Incontinence
  • Urinary Incontinence, Stress
Behavioral: Knack therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2008
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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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P50HD044406( U.S. NIH Grant/Contract )
1P50HD044406 ( U.S. NIH Grant/Contract )
IRBMED# 2002-0635 ( Other Identifier: University of Michigan IRB )
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University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
University of Michigan
July 2005

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