Urinary Incontinence, Urinary Incontinence, Stress
Conditions
Keywords
pelvic muscle therapy, urinary incontinence therapy, stress incontinence intervention, incontinence intervention, Incontinence, SUI, Stress Incontinence
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.
Interventions
BEHAVIORALKnack therapy
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. | — |
Countries
United States
Outcome results
None listed