IRIS: Incontinence Research Intervention Study

Phase 1

Completed

• Conditions: Urinary Incontinence; Urinary Incontinence, Stress

• Registration Number: NCT00125177
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study Start: 2003-01
• Status Verified: 2005-07
• Study First Submitted: 2005-07-27
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-07-29
• Study Completion: 2008-04
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan, School of Nursing; 🇺🇸 Ann Arbor, Michigan, United States