Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder

February 12, 2019 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • qualifying symptoms in 3 months prior to enrollment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary incontinence symptoms for participant with bladder symptoms
Time Frame: 3 months after workshop completion
  1. 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
3 months after workshop completion
bowel incontinence symptoms for participant with bowel symptoms
Time Frame: 3 months after workshop completion
  1. 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
3 months after workshop completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
geriatric self-efficacy score for urinary incontinence
Time Frame: 3 months after workshop completion
Difference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale
3 months after workshop completion
barriers to care-seeking for urinary incontinence
Time Frame: 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 months after workshop completion
barriers to care-seeking for accidental bowel leakage
Time Frame: 3 months after workshop completion
Barriers to Care-Seeking for Accidental Bowel Leakage responses - difference from baseline to 3 month follow up
3 months after workshop completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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