Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

Study Overview
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Brief Summary
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The study is to pilot-test an innovative, combined urinary/bowel continence workshop in two Wisconsin communities. Between 8-15 women with incontinence will be enrolled in each of the two pilot communities and will complete three 90-minute workshop sessions over a 6 week period.

Detailed Description
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The pilot study will use mixed methods to compare pre- and post-workshop data about urinary and bowel incontinence symptoms and care-seeking from workshop participants as well as information about workshop acceptability from workshop participants and community partners. The study is expected to last 6 months from initial IRB approval through data analysis and workshop revision. This research will provide preliminary data for a larger test of this workshop in four diverse Wisconsin Communities, followed by a randomized, controlled trial and subsequent dissemination research study.

Official Title
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Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder

Conditions
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Urinary Incontinence, Fecal Incontinence, Accidental Bowel Leakage

Intervention / Treatment
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* Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: qualifying symptoms in 3 months prior to enrollment Exclusion Criteria: receiving new treatment for qualifying symptoms in 3 months prior to enrollment

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot workshop<br>Participants attend intervention. No control arm | Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder<br>* 3 workshop sessions over a one-month period using self-efficacy and health behavior change to improve incontinence symptoms and promote care-seeking if symptoms do not improve sufficiently<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary incontinence symptoms for participant with bladder symptoms | Change in Urinary Distress Inventory-6 Subscale of Pelvic Floor Distress Inventory-20 from baseline Patient Global Impression of Improvement in urinary symptoms at 3 month follow up | 3 months after workshop completion | 
| bowel incontinence symptoms for participant with bowel symptoms | Change in Colorectal Anal Distress Inventory-8 Subscale of Pelvic Floor Distress Inventory-20 from baseline Patient Global Impression of Improvement in bowel symptoms at 3 month follow up | 3 months after workshop completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| geriatric self-efficacy score for urinary incontinence | Difference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale | 3 months after workshop completion | 
| barriers to care-seeking for urinary incontinence | Score on the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) at three month follow up as compared to baseline | 3 months after workshop completion | 
| barriers to care-seeking for accidental bowel leakage | Barriers to Care-Seeking for Accidental Bowel Leakage responses - difference from baseline to 3 month follow up | 3 months after workshop completion |