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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50HD044406 | U.S. NIH Grant/Contract | View source | |
| IRBMED# 2002-0635 | Other Identifier | University of Michigan IRB |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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.
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knack therapy | Behavioral |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janis M Miller, PhD, APRN | University of Michigan, School of Nursing, Dept. Obstetrics & Gynecology | Principal Investigator |
| John OL DeLancey, MD | University of Michigan, Obstetrics & Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, School of Nursing | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |