Urinary IncontinenceNCT02671747
Pilot: Mind Over Matter: Healthy Bowels, Healthy Bladder
A study testing Mind Over Matter; Healthy Bowels, Healthy Bladder in people with Urinary Incontinence and Fecal Incontinence, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Fecal Incontinence, Accidental Bowel Leakage
- 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
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 1 Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- qualifying symptoms in 3 months prior to enrollment
Who cannot join
- receiving new treatment for qualifying symptoms in 3 months prior to enrollment
About this study
Official title: 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.
Read the 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.
- Being tested
- Mind Over Matter; Healthy Bowels, Healthy Bladder
- Medical subject headings
- Urinary Incontinence, Fecal Incontinence
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
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
| Study group | Role | What they receive |
|---|---|---|
| Pilot workshop | Experimental | Participants attend intervention. No control arm 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.
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
Measured: 3 months after workshop completion
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
Measured: 3 months after workshop completion
Secondary outcomes (3)
geriatric self-efficacy score for urinary incontinence
Difference between baseline and 3 month follow up on Geriatric Self-Efficacy for Urinary Incontinence scale
Measured: 3 months after workshop completion
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
Measured: 3 months after workshop completion
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
Measured: 3 months after workshop completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startAug 2015
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Brown, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671747
- Sponsor's protocol ID
- 2015-0942
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing for Mind Over Matter: Healthy Bowels, Healthy Bladder
- ClinicalTrials.gov ID
- NCT02671747
- Acronym / sponsor ID
- 2015-0942
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot workshop | Experimental | Behavioral: Mind Over Matter; Healthy Bowels, Healthy BladderParticipants attend intervention. No control arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- qualifying symptoms in 3 months prior to enrollment
Key exclusion criteria (1 listed)
- receiving new treatment for qualifying symptoms in 3 months prior to enrollment
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 Bladder3 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 | Behavioural | Pilot workshop |
Primary outcome
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
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 secondary outcomes
geriatric self-efficacy score for urinary incontinence
Time frame: 3 months after workshop completion
barriers to care-seeking for urinary incontinence
Time frame: 3 months after workshop completion
barriers to care-seeking for accidental bowel leakage
Time frame: 3 months after workshop completion
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 15 Feb 2019.
- Individual participant dataSharing planned: Yes
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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
Questions about this trial
What is this clinical trial studying?
A study testing Mind Over Matter; Healthy Bowels, Healthy Bladder in people with Urinary Incontinence and Fecal Incontinence, run by University of Wisconsin, Madison.
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 1 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
urinary incontinence symptoms for participant with bladder symptoms (time frame: 3 months after workshop completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.