Clinical trial NCT00125177: IRIS: Incontinence Research Intervention Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence
Urinary Incontinence, Stress
Keywords: pelvic muscle therapy
urinary incontinence therapy
stress incontinence intervention
incontinence intervention
Incontinence
SUI
Stress Incontinence
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-07-29
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology
name: Janis M Miller, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan, Obstetrics & Gynecology
name: John OL DeLancey, MD
role: STUDY_DIRECTOR
References: