Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671747
• Other study ID #: 2015-0942
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: October 1, 2016

Study information

• Verified date: February 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 1, 2016
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Accidental Bowel Leakage
• Enuresis
• Fecal Incontinence
• Urinary Incontinence

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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