IRIS: Incontinence Research Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence Urinary Incontinence, Stress

Keywords

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pelvic muscle therapy urinary incontinence therapy stress incontinence intervention incontinence intervention Incontinence SUI Stress Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Knack therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Janis M Miller, PhD, APRN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology

John OL DeLancey, MD

Role: STUDY_DIRECTOR

University of Michigan, Obstetrics & Gynecology

Locations

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University of Michigan, School of Nursing

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1P50HD044406

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRBMED# 2002-0635

Identifier Type: OTHER