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Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02671747
Enrollment
56
Registered
2016-02-02
Start date
2015-08-31
Completion date
2016-10-01
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Bowel Leakage, Fecal Incontinence, Urinary Incontinence

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.

Interventions

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

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
urinary incontinence symptoms for participant with bladder symptoms3 months after workshop completion1. 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
bowel incontinence symptoms for participant with bowel symptoms3 months after workshop completion1. 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

Secondary

MeasureTime frameDescription
geriatric self-efficacy score for urinary incontinence3 months after workshop completionDifference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale
barriers to care-seeking for urinary incontinence3 months after workshop completionScore 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 leakage3 months after workshop completionBarriers to Care-Seeking for Accidental Bowel Leakage responses - difference from baseline to 3 month follow up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026