Overview

This trial is active, not recruiting.

Conditions urinary incontinence, fecal incontinence, accidental bowel leakage
Treatment mind over matter; healthy bowels, healthy bladder
Sponsor University of Wisconsin, Madison
Start date August 2015
End date January 2018
Trial size 30 participants
Trial identifier NCT02671747, 2015-0942

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
Participants attend intervention. No control arm
mind over matter; healthy bowels, healthy bladder
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

Primary Outcomes

Measure
urinary incontinence symptoms for participant with bladder symptoms
time frame: 3 months after workshop completion
bowel incontinence symptoms for participant with bowel symptoms
time frame: 3 months after workshop completion

Secondary Outcomes

Measure
geriatric self-efficacy score for urinary incontinence
time frame: 3 months after workshop completion
barriers to care-seeking for urinary incontinence
time frame: 3 months after workshop completion
barriers to care-seeking for accidental bowel leakage
time frame: 3 months after workshop completion

Eligibility Criteria

Female participants at least 50 years old.

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

Additional Information

Official title Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder
Principal investigator Heidi Brown, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.