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 Incontinence Stress Urinary Incontinence SUI Stress Incontinence	Behavior: Knack therapy	Phase I Phase II

Further Study Details: 

Primary Outcomes: 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 Outcomes: Long-term success (3-month 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.
Expected Total Enrollment:  320

This proposal aims to develop and test, in a general population of women with 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: (1) develop a logistic regression model to predict success with the Knack, (2) validate the model by determining the proportion of people who succeed according to who is predicted to succeed, and (3) 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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 age eighteen
• Pregnant or expecting to become pregnant
• Untreated urinary tract infection
• Pronounced pain or discomfort with pelvic exams
• History of neurologic conditions

Please refer to this study by ClinicalTrials.gov identifier  NCT00125177

Ruta B Misiunas, BA      734-763-4884    IRISSTUDY@umich.edu

Michigan
      University of Michigan, School of Nursing, Ann Arbor,  Michigan,  48109,  United States; Recruiting

Study chairs or principal investigators

Janis M Miller, PhD, APRN,  Principal Investigator,  University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology   
John OL DeLancey, MD,  Study Director,  University of Michigan, Obstetrics & Gynecology   

Study ID Numbers:  P50 HD 044406; IRB# 2002-0635
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125177
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02