search
Back to results

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
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Incontinence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 29, 2016
    Last Updated
    February 12, 2019
    Sponsor
    University of Wisconsin, Madison
    search

    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

    We'll reach out to this number within 24 hrs