IRIS: Incontinence Research Intervention Study

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125177
• Other study ID #: P50HD044406
• Secondary ID: 1P50HD044406IRBM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2005
• Last updated: November 9, 2010
• Start date: January 2003
• Est. completion date: April 2008

Study information

• Verified date: July 2005
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Knack therapy

Locations

Country	Name	City	State
United States	University of Michigan, School of Nursing	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   Study Homepage