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Completed

NCT Number: NCT00125177

IRIS: Incontinence Research Intervention Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan, School of Nursing

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knack therapy

Behavioral

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2008
First posted
Jul 29, 2005
Registry last updated
Nov 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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