Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT02671747
Collaborator
(none)
56
1
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder
N/A

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
Actual Enrollment :
56 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pilot workshop

Participants attend intervention. No control arm

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

Outcome Measures

Primary Outcome Measures

  1. urinary incontinence symptoms for participant with bladder symptoms [3 months after workshop completion]

    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

  2. bowel incontinence symptoms for participant with bowel symptoms [3 months after workshop completion]

    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

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Wisconsin, Madison

Investigators

  • Principal Investigator: Heidi Brown, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02671747
Other Study ID Numbers:
  • 2015-0942
First Posted:
Feb 2, 2016
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2019