- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03140852
Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM) (SHAIP)
August 20, 2025 updated by: University of Wisconsin, Madison
The goal of this study is to obtain data about the effectiveness, reach, adoption, and implementation potential of an innovative, combined urinary/bowel continence workshop through a randomized controlled trial in six Wisconsin communities.
This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.
We hypothesize that workshop participants will experience improvements in urinary and bowel incontinence symptoms, will have increased levels of care-seeking and self-efficacy for these conditions, and will maintain the self-management strategies taught in the workshop 3 months following completion of the workshop.
We further hypothesize that this workshop will reach its intended target population (independent senior women with incontinence) and will improve their mental health by destigmatizing the condition of incontinence.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin-Madison School of Medicine and Public Health
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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
Yes
Description
Inclusion Criteria:
- qualifying symptoms within last 3 months
- able to speak English
- lives independently
Exclusion Criteria:
- new treatment for target symptoms within last 3 months
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: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment
Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017.
|
This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.
|
|
Other: Control
Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017.
|
This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Improvement
Time Frame: 3 months after treatment group completes intervention
|
Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence
|
3 months after treatment group completes intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic Floor Distress Inventory-20
Time Frame: 3 months after treatment group completes intervention
|
validated instrument
|
3 months after treatment group completes intervention
|
|
Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)
Time Frame: 3 months after treatment group completes intervention
|
validated instrument
|
3 months after treatment group completes intervention
|
|
Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
Time Frame: 3 months after treatment group completes intervention
|
validated instrument
|
3 months after treatment group completes intervention
|
|
Barriers to Incontinence Care-seeking (BICS-Q)
Time Frame: 3 months after treatment group completes intervention
|
validated instrument
|
3 months after treatment group completes intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heidi Brown, MD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
April 25, 2017
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
May 2, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
August 22, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Digestive System Diseases
- Gastrointestinal Diseases
- Rectal Diseases
- Urinary Incontinence
- Fecal Incontinence
Other Study ID Numbers
- 2017-0133 (Other Identifier: MD Anderson)
- A532840 (Other Identifier: UW Madison)
- SMPH\OBSTET & GYNECOL\RESEARCH (Other Identifier: UW Madison)
- 4K12DK100022 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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