IRIS: Incontinence Research Intervention Study
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.
Urinary Incontinence, Stress
Behavioral: Knack therapy
|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|
- 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.
- 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.
|Study Start Date:||January 2003|
|Study Completion Date:||April 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125177
|United States, Michigan|
|University of Michigan, School of Nursing|
|Ann Arbor, Michigan, United States, 48109|
|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|