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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR012011-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). UI severity increases with age and the financial cost exceeds $19 billion per year . The Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. They also may decrease symptoms of urgency and frequency that do not entail UI, but greatly reduce the quality of life for nearly 1 in 11 US women.
The study will attempt to accomplish 3 aims:
Aim 1: Compare outcomes of the two-hour BH Class with the condensed DVD version.
To accomplish this aim we will conduct a comparative effectiveness trial of 600 women 55 years and older randomized to BH Class or DVD. Women will be followed for 24 months post-intervention in order to assess long-term outcomes and sustainability.
Aim 2: Conduct an economic analysis comparing the two-hour BH Class with the DVD version. Describing the costs, quality of life, and analyzing the willingness to pay and employment/ productivity data will be the primary economic focus of this study.
Aim 3: Conduct a qualitative analysis to gain insight into elements of the intervention that contribute to sustainability.
Inclusion/Exclusion Criteria
Inclusion:
Exclusion:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Instructional DVD Intervention | Other | Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once |
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| Bladder Health Class Intervention | Other | Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instructional DVD | Behavioral | Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once. |
| Measure | Description | Time Frame |
|---|---|---|
| Translating Unique Learning for Incontinence Prevention (TULIP) | Prevention study for Urinary Incontinence in women over the age of 55 who are fully continent (do not leak urine at all) or mildly continent (leak small drops of urine on occasion). This study will measure the effectiveness of 2 interventions: a bladder health instruction session or Bladder Health DVD administration. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Sampselle, PHD, RN | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Nursing | Ann Arbor | Michigan | 48109 | United States | ||
| University of Pennsylvania Department of Urology |
Manuscript preparation for data dissemination is currently in progress.
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053206 | Nocturnal Enuresis |
| D053201 | Urinary Bladder, Overactive |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Bladder Health Class | Behavioral | Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit. |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 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 |
| D004775 | Enuresis |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D001745 | Urinary Bladder Diseases |