IRIS: Incontinence Research Intervention Study

University of Michigan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Incontinence, Stress; Urinary Incontinence

Treatments: Behavioral: Knack therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00125177

IRBMED# 2002-0635 (Other Identifier)

1P50HD044406 (U.S. NIH Grant/Contract)

P50HD044406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)