Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder
Primary Purpose
Urinary Incontinence, Fecal Incontinence, Accidental Bowel Leakage
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mind Over Matter; Healthy Bowels, Healthy Bladder
Sponsored by
About this trial
This is an interventional other trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- qualifying symptoms in 3 months prior to enrollment
Exclusion Criteria:
- receiving new treatment for qualifying symptoms in 3 months prior to enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot workshop
Arm Description
Participants attend intervention. No control arm
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
geriatric self-efficacy score for urinary incontinence
Difference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale
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
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
Full Information
NCT ID
NCT02671747
First Posted
January 29, 2016
Last Updated
February 12, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02671747
Brief Title
Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder
Official Title
Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 1, 2016 (Actual)
Study Completion Date
October 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Fecal Incontinence, Accidental Bowel Leakage
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot workshop
Arm Type
Experimental
Arm Description
Participants attend intervention. No control arm
Intervention Type
Behavioral
Intervention Name(s)
Mind Over Matter; Healthy Bowels, Healthy Bladder
Intervention Description
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 Outcome Measure Information:
Title
urinary incontinence symptoms for participant with bladder symptoms
Description
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
Time Frame
3 months after workshop completion
Title
bowel incontinence symptoms for participant with bowel symptoms
Description
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
Time Frame
3 months after workshop completion
Secondary Outcome Measure Information:
Title
geriatric self-efficacy score for urinary incontinence
Description
Difference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale
Time Frame
3 months after workshop completion
Title
barriers to care-seeking for urinary incontinence
Description
Score on the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) at three month follow up as compared to baseline
Time Frame
3 months after workshop completion
Title
barriers to care-seeking for accidental bowel leakage
Description
Barriers to Care-Seeking for Accidental Bowel Leakage responses - difference from baseline to 3 month follow up
Time Frame
3 months after workshop completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
qualifying symptoms in 3 months prior to enrollment
Exclusion Criteria:
receiving new treatment for qualifying symptoms in 3 months prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Brown, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder
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