NCT00125177

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Urinary Incontinence, Stress

Interventions

Type	Name	Description
BEHAVIORAL	Knack therapy

Timeline

• Start date: 2003-01-01
• Completion: 2008-04-01
• First posted: 2005-07-29
• Last updated: 2010-11-10

Locations

1 site across 1 country: United States