IRIS: Incontinence Research Intervention Study
|ClinicalTrials.gov Identifier: NCT00125177|
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : November 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Urinary Incontinence, Stress||Behavioral: Knack therapy||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2003|
|Study Completion Date :||April 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|