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Sponsors and Collaborators: |
University of Michigan Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00125177 |
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 |
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Urinary Incontinence Urinary Incontinence, Stress |
Behavioral: Knack therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 320 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | August 2007 |
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:
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 older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ruta B Misiunas, BA | 734-763-4884 | IRISSTUDY@umich.edu |
United States, Michigan | |
University of Michigan, School of Nursing | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Janis M. Miller, PhD, APRN 734-764-4545 janismm@umich.edu | |
Principal Investigator: Janis M Miller, PhD, APRN | |
Sub-Investigator: Dee E. Fenner, MD | |
Sub-Investigator: Gwi-Ryung Son, PhD |
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 |
Study ID Numbers: | P50 HD 044406, IRB# 2002-0635 |
Study First Received: | July 27, 2005 |
Last Updated: | September 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00125177 |
Health Authority: | United States: Institutional Review Board |
pelvic muscle therapy urinary incontinence therapy stress incontinence intervention incontinence intervention |
Incontinence SUI Stress Incontinence |
Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases |
Urination Disorders Stress Urinary Incontinence |
Urological Manifestations |