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Clinical Trials/NCT02671747
NCT02671747CompletedNot Applicable

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

University of Wisconsin, Madison0 sites56 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Primary Endpoint
bowel incontinence symptoms for participant with bowel symptoms

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria

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

Arms & Interventions

Pilot workshop

Experimental

Participants attend intervention. No control arm

Intervention: Mind Over Matter; Healthy Bowels, Healthy Bladder (Behavioral)

Outcomes

Primary Outcomes

bowel incontinence symptoms for participant with bowel symptoms

Time Frame: 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

Time Frame: 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 Outcomes

  • geriatric self-efficacy score for urinary incontinence(3 months after workshop completion)
  • barriers to care-seeking for urinary incontinence(3 months after workshop completion)
  • barriers to care-seeking for accidental bowel leakage(3 months after workshop completion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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