IRIS: Incontinence Research Intervention Study

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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.

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

Conditions
-----------------
Urinary Incontinence, Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Behavioral: Knack therapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Knack therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic muscle therapy, urinary incontinence therapy, stress incontinence intervention, incontinence intervention, Incontinence, SUI, Stress Incontinence