IRIS: Incontinence Research Intervention Study
This study has been completed.
Sponsor:
University of Michigan
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00125177
First received: July 27, 2005
Last updated: November 9, 2010
Last verified: July 2005
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Purpose
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 Urinary Incontinence, Stress |
Behavioral: Knack therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
| Estimated Enrollment: | 320 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 the age of eighteen
- Pregnant or expecting to become pregnant
- Untreated urinary tract infection
- Pronounced pain or discomfort with pelvic exams
- History of neurologic conditions
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125177
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125177
Locations
| United States, Michigan | |
| University of Michigan, School of Nursing | |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00125177 History of Changes |
| Other Study ID Numbers: | P50HD044406 1P50HD044406 IRBMED# 2002-0635 |
| Study First Received: | July 27, 2005 |
| Last Updated: | November 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
pelvic muscle therapy urinary incontinence therapy stress incontinence intervention incontinence intervention |
Incontinence SUI Stress Incontinence |
Additional relevant MeSH terms:
|
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms |
Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 23, 2016