Expired Study
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Ann Arbor, Michigan 48109


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.


Study summary:

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.


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


NCT ID:

NCT00125177


Primary Contact:

Principal Investigator
Janis M Miller, PhD, APRN
University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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