Fecal Incontinence in Old AgeSHAIPNCT03140852
Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
A study testing Mind Over Matter; Healthy Bowels, Healthy Bladder in people with Fecal Incontinence in Old Age and Urinary Incontinence in Old Age, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence in Old Age, Urinary Incontinence in Old Age
- What is being tested?
- Mind Over Matter; Healthy Bowels, Healthy Bladder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- qualifying symptoms within last 3 months
- able to speak English
- lives independently
Who cannot join
- new treatment for target symptoms within last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
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.
- Being tested
- Mind Over Matter; Healthy Bowels, Healthy Bladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Over Matter; Healthy Bowels, Healthy BladderBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017. Receives: Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder |
| Control | Other | Completes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017. Receives: Behavioral: Mind Over Matter; Healthy Bowels, Healthy Bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Improvement
Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence
Measured: 3 months after treatment group completes intervention
Secondary outcomes (4)
Pelvic Floor Distress Inventory-20
validated instrument
Measured: 3 months after treatment group completes intervention
Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)
validated instrument
Measured: 3 months after treatment group completes intervention
Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)
validated instrument
Measured: 3 months after treatment group completes intervention
Barriers to Incontinence Care-seeking (BICS-Q)
validated instrument
Measured: 3 months after treatment group completes intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start25 Apr 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal Incontinence in Old AgeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Partnership Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Heidi Brown, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140852
- Sponsor's protocol ID
- 2017-0133
- Other IDs
- A532840, SMPH\OBSTET & GYNECOL\RESEARCH, 4K12DK100022
- Acronym
- SHAIP
- Status last verified
- Dec 2019
- First submitted
- 2 May 2017
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown HW, Braun EJ, Wise ME, Myers S, Li Z, Sampene E, Jansen SM, Moberg DP, Mahoney JE, Rogers RG. Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):600-610. doi: 10.1097/AOG.0000000000003422.
PubMed 31403596
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Continence Promotion: Sustaining Healthy Aging in Place (SHAIP) Through Mind Over Matter (MOM)
- ClinicalTrials.gov ID
- NCT03140852
- Acronym / sponsor ID
- SHAIP / 2017-0133
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Partnership Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Behavioral: Mind Over Matter; Healthy Bowels, Healthy BladderCompletes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the spring 2017. |
| Control | Other | Behavioral: Mind Over Matter; Healthy Bowels, Healthy BladderCompletes the Mind Over Matter; Healthy Bowels, Healthy Bladder workshop in the fall 2017. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- qualifying symptoms within last 3 months
- able to speak English
- lives independently
Key exclusion criteria (1 listed)
- new treatment for target symptoms within last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind Over Matter; Healthy Bowels, Healthy BladderThis 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. | Behavioural | Control, Treatment |
Primary outcome
Symptom Improvement
Time frame: 3 months after treatment group completes intervention
Patient Global Impression of Improvement (PGI-I) regarding bladder or bowel incontinence
4 secondary outcomes
Pelvic Floor Distress Inventory-20
Time frame: 3 months after treatment group completes intervention
Geriatric Self-Efficacy for Urinary Incontinence (GSE-UI)
Time frame: 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
Barriers to Incontinence Care-seeking (BICS-Q)
Time frame: 3 months after treatment group completes intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 31403596Brown HW, Braun EJ, Wise ME, Myers S, Li Z, Sampene E, Jansen SM, Moberg DP, Mahoney JE, Rogers RG. Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):600-610. doi: 10.1097/AOG.0000000000003422.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Brown, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Over Matter; Healthy Bowels, Healthy Bladder in people with Fecal Incontinence in Old Age and Urinary Incontinence in Old Age, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Improvement (time frame: 3 months after treatment group completes intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.