IRIS: Incontinence Research Intervention Study
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|