Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

Not Applicable

Completed

• Conditions: Urinary Incontinence; Fecal Incontinence; Accidental Bowel Leakage
• Interventions: Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder

• Registration Number: NCT02671747
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Primary Completion: 2016-10-01
• Study Completion: 2016-10-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria

• receiving new treatment for qualifying symptoms in 3 months prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot workshop	Mind Over Matter; Healthy Bowels, Healthy Bladder	Participants attend intervention. No control arm

Primary Outcome Measures

Name	Time	Method
bowel incontinence symptoms for participant with bowel symptoms	3 months after workshop completion	1. Change in Colorectal Anal Distress Inventory-8 Subscale of Pelvic Floor Distress Inventory-20 from baseline; 2. Patient Global Impression of Improvement in bowel symptoms at 3 month follow up
urinary incontinence symptoms for participant with bladder symptoms	3 months after workshop completion	1. Change in Urinary Distress Inventory-6 Subscale of Pelvic Floor Distress Inventory-20 from baseline; 2. Patient Global Impression of Improvement in urinary symptoms at 3 month follow up

Secondary Outcome Measures

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