Text Size

IRIS: Incontinence Research Intervention Study

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00125177
First received: July 27, 2005
Last updated: November 9, 2010
Last verified: July 2005
History of Changes
  Purpose

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 Intervention Phase
Urinary Incontinence
Urinary Incontinence, Stress
 Behavioral: Knack therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 320
Study Start Date: January 2003
Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125177

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

Additional Information:
Study Homepage  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00125177     History of Changes
Other Study ID Numbers: P50 HD 044406, 1P50HD044406, IRBMED# 2002-0635
Study First Received: July 27, 2005
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board

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
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013