Incontinence, UrinaryNCT03976414
Mind Over Matter: Electronic Bladder and Bowel Continence Self-management Program
An observational study of Incontinence, Urinary and Incontinence Bowel, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The objective of this study is to (1) use participatory ergonomics to adapt and in-person 3-session intervention: Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM) to an electronic program (eMOM), and to (2) compare and characterize eMOM's reach when marketed via community agencies versus Facebook advertising… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Urinary, Incontinence Bowel
- What is being tested?
- eMOM
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 May 2020
- Phase
- Observational
- 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 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: While eMOM will be promoted specifically for older women, women of any age may access the program and participate in the study if they so choose.
Who may be able to join
- be able to access the eMOM website via internet
- must be able to speak and read English
- at least 18 years old
- female.
Who cannot join
- no access to internet
- no email address
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
Official title: Reach and Teach: Translating "Mind Over Matter: Healthy Bowels, Healthy Bladder" for Digital Delivery
The objective of this study is to (1) use participatory ergonomics to adapt and in-person 3-session intervention: Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM) to an electronic program (eMOM), and to (2) compare and characterize eMOM's reach when marketed via community agencies versus Facebook advertising and to collect qualitative and quantitative data about effectiveness and uptake of key behaviors using electronic surveys and phone interviews. The study will also collect information from community agencies that might implement eMOM about its perceived value and their willingness and capacity to implement such a program.
Read the detailed description
More than half of patients hospitalized with serious illness rated urinary and bowel incontinence as a state worse than death in a 2016 JAMA (The Journal of the American Medical Association) internal medicine study - worse than relying on a breathing machine, being unable to get out of bed, or being confused all the time. Unfortunately, over 60% of community-dwelling women over age 65 suffer from urinary and/or bowel incontinence, accounting for a combined annual cost in excess of $30 billion. In addition to their impact on quality of life, social isolation, and depression, urinary and bowel incontinence increase caregiver burnout, risk for falls, hospitalization, and nursing home placement. However, despite the existence of effective treatments, over half of women with urinary incontinence and two-thirds of women with bowel incontinence do not seek medical care. Interventions to promote continence in healthcare settings thus reach fewer than half of those in need.
At University of Wisconsin, research team developed "Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM), which is a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence. Delivered by a trained facilitator, MOM allows senior women to improve their symptoms without seeking medical care. In the randomized, controlled trial (RCT) including 122 women in 6 Wisconsin communities, more than 70% of participants (versus 23% of controls, p<.0001) achieved improvement in urinary incontinence and 55% (versus 26% of controls, p = .0015) achieved improvement in bowel incontinence three months following completion of the program, corresponding to a number-needed-to-treat of 3 for urinary incontinence improvement and 4 for bowel incontinence improvement.
However, community-based, in-person programs like MOM continue to suffer limited adoption, implementation, and reach. Many agencies that adopt and implement such health promotion programs are under-resourced and often staffed by volunteers. To ensure intervention fidelity, programs like MOM require a large commitment from their resource-stressed hosting agencies. Implemented using a "train the trainer" approach organized by the Wisconsin Institute for Healthy Aging (WIHA), MOM requires community facilitators to attend a 2-day training and then run the workshop series at least twice annually. In addition to the 2-day training, it requires approximately 24 person-hours to offer a single MOM workshop series. If the trained facilitator leaves or is redirected to other activities, the community agency can no longer implement or maintain the program without sending another staff member to be trained. In addition to these hurdles at the organization level, there are barriers at the individual level.
In a recent collaboration with the Survey of the Health of Wisconsin (SHOW), it was observed that fewer than 20% of women with incontinence (mean age 55 years old) reported being likely to attend a continence promotion program with the current, in-person MOM format. In qualitative interviews, women expressed concerns about the time commitment, caregiver responsibilities at home, issues related to travel (inclement weather, excessive distance to reach a community center), and privacy, given the sensitive nature of incontinence. In contrast, 65% of women with incontinence reported being likely to participate in an electronic continence promotion program, increasing potential reach three-fold.
Adaptation of the in-person MOM workshop to an electronic format (eMOM) has the potential to overcome both individual and organizational hurdles, maximizing reach and minimizing barriers to consistent implementation and maintenance. Women with incontinence can complete the modules in privacy, at their convenience, and at their own pace. In contrast to the commitment required for a community agency to implement the in-person MOM workshop, eMOM can be implemented using whatever strategies the agency uses to share other electronic resources with their members. eMOM can also be implemented via mass media, such as Facebook. Women age 65+ account for 11.6% of all Facebook users, and there are more than 200,000 monthly active users in this demographic in Wisconsin alone.
The proposed research will provide invaluable information about the feasibility and reach of implementing an electronic health promotion program through mass media versus through existing community agencies - information applicable not just to continence promotion but also to other health promotion programs trying to overcome similar barriers to reach, implementation, and maintenance.
- Conditions
- Incontinence, Urinary, Incontinence Bowel
- Being tested
- eMOM
- Medical subject headings
- Urinary Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMOMOther
Also called Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM)
The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence.
| Study group | Role | What they receive |
|---|---|---|
| eMOM website users | Any woman who visits the "research" tab on the eMOM website will see an invitation to participate in a research study about the impact of the website on her bladder and bowel symptoms. Women may use the intervention (the website) regardless of whether they opt to participate in the research study.
The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence. Receives: Other: eMOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response on global perception of improvement (GPI) tool at 4 months
Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement.
Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse
Measured: 4 months
Secondary outcomes (11)
Change in the response of Global patient satisfaction question (PSQ)
Patient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)
Measured: 1 month, 4 months, 6 months
Change in patient estimated percent improvement (EPI)
For EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)
Measured: 1 month, 4 months, 6 months
Change in response on global perception of improvement (GPI) at 1 month and 6 months
Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement.
Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse
Measured: 1 month, 6 month
Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
ICIQ-UI is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. It is scored on a scale from 0-21. Based on the score participant can be placed in four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)
Measured: Baseline, 1 month, 4 month, 6 month
Differences in scores of the St. Mark's Incontinence Scale (aka Vaizey)
St. Mark's Incontinence Scale (aka Vaizey) will be used to assess the severity and the outcome of MOM intervention
Never: no episodes in the past 4 weeks rarely: 1 episode in the past 4 weeks sometimes: > 1 episode in the past 4 weeks, but,1 a week; Weekly: 1 or more episodes a week but,1 a day Daily: 1 or more episodes a day
Scores will be assigned for each row (Never=0, Rarely=1, Sometimes=2, Weekley=3, Daily=4 )
Score will be added from each row. Cumulative minimum score=0 perfect continence; Cumulative maximum score will be 24= totally incontinence
Measured: baseline, 1 month, 4 month, 6 month
Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises
Frequency of pelvic floor muscle exercises
Measured: baseline, 1 month, 4 month, 6 month
Self-reported behavior changes: change in fluid intake
Self-reported behavior changes: fluid intake
Measured: baseline, 1 month, 4 month, 6 month
Self-reported behavior changes: change in fiber intake
Self-reported behavior changes: change in fiber intake
Measured: baseline, 1 month, 4 month, 6 month
Self-reported coping changes: change in types of pad used
Self-reported coping changes: change in types of pad used
Measured: baseline, 1 month, 4 month, 6 month
Self-reported coping changes: change in number of pads used
Self-reported coping changes: change in number of pads used
Measured: baseline, 1 month, 4 month, 6 month
Self-reported changes: change in the money-spent on buying products to manage their incontinence
It will be measured by asking participants question that how much money have they spent on products (such as pads, undergarments, or plugs) to manage their bladder and/or bowel symptoms in the last month.
Measured: baseline, 1 month, 4 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrinaryStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 260 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, UW-Madison Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976414
- Sponsor's protocol ID
- 2018-1147
- Other IDs
- SMPH/OBSTET & GYNECOL/OBSTET &, A532800
- Status last verified
- Sep 2020
- First submitted
- 6 May 2019
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Reach and Teach: Translating "Mind Over Matter: Healthy Bowels, Healthy Bladder" for Digital Delivery
- ClinicalTrials.gov ID
- NCT03976414
- Acronym / sponsor ID
- 2018-1147
- Conditions
- Incontinence, Urinary, Incontinence Bowel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 6 Jun 2019 (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 objective of this study is to (1) use participatory ergonomics to adapt and in-person 3-session intervention: Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM) to an electronic program (eMOM), and to (2) compare and characterize eMOM's reach when marketed via community agencies versus Facebook advertising and to collect qualitative and quantitative data about effectiveness and uptake of key behaviors using electronic surveys and phone interviews. The study will also collect information from community agencies that might implement eMOM about its perceived value and their willingness and capacity to implement such a program.
Detailed description
More than half of patients hospitalized with serious illness rated urinary and bowel incontinence as a state worse than death in a 2016 JAMA (The Journal of the American Medical Association) internal medicine study - worse than relying on a breathing machine, being unable to get out of bed, or being confused all the time. Unfortunately, over 60% of community-dwelling women over age 65 suffer from urinary and/or bowel incontinence, accounting for a combined annual cost in excess of $30 billion. In addition to their impact on quality of life, social isolation, and depression, urinary and bowel incontinence increase caregiver burnout, risk for falls, hospitalization, and nursing home placement. However, despite the existence of effective treatments, over half of women with urinary incontinence and two-thirds of women with bowel incontinence do not seek medical care. Interventions to promote continence in healthcare settings thus reach fewer than half of those in need.
At University of Wisconsin, research team developed "Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM), which is a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence. Delivered by a trained facilitator, MOM allows senior women to improve their symptoms without seeking medical care. In the randomized, controlled trial (RCT) including 122 women in 6 Wisconsin communities, more than 70% of participants (versus 23% of controls, p<.0001) achieved improvement in urinary incontinence and 55% (versus 26% of controls, p = .0015) achieved improvement in bowel incontinence three months following completion of the program, corresponding to a number-needed-to-treat of 3 for urinary incontinence improvement and 4 for bowel incontinence improvement.
However, community-based, in-person programs like MOM continue to suffer limited adoption, implementation, and reach. Many agencies that adopt and implement such health promotion programs are under-resourced and often staffed by volunteers. To ensure intervention fidelity, programs like MOM require a large commitment from their resource-stressed hosting agencies. Implemented using a "train the trainer" approach organized by the Wisconsin Institute for Healthy Aging (WIHA), MOM requires community facilitators to attend a 2-day training and then run the workshop series at least twice annually. In addition to the 2-day training, it requires approximately 24 person-hours to offer a single MOM workshop series. If the trained facilitator leaves or is redirected to other activities, the community agency can no longer implement or maintain the program without sending another staff member to be trained. In addition to these hurdles at the organization level, there are barriers at the individual level.
In a recent collaboration with the Survey of the Health of Wisconsin (SHOW), it was observed that fewer than 20% of women with incontinence (mean age 55 years old) reported being likely to attend a continence promotion program with the current, in-person MOM format. In qualitative interviews, women expressed concerns about the time commitment, caregiver responsibilities at home, issues related to travel (inclement weather, excessive distance to reach a community center), and privacy, given the sensitive nature of incontinence. In contrast, 65% of women with incontinence reported being likely to participate in an electronic continence promotion program, increasing potential reach three-fold.
Adaptation of the in-person MOM workshop to an electronic format (eMOM) has the potential to overcome both individual and organizational hurdles, maximizing reach and minimizing barriers to consistent implementation and maintenance. Women with incontinence can complete the modules in privacy, at their convenience, and at their own pace. In contrast to the commitment required for a community agency to implement the in-person MOM workshop, eMOM can be implemented using whatever strategies the agency uses to share other electronic resources with their members. eMOM can also be implemented via mass media, such as Facebook. Women age 65+ account for 11.6% of all Facebook users, and there are more than 200,000 monthly active users in this demographic in Wisconsin alone.
The proposed research will provide invaluable information about the feasibility and reach of implementing an electronic health promotion program through mass media versus through existing community agencies - information applicable not just to continence promotion but also to other health promotion programs trying to overcome similar barriers to reach, implementation, and maintenance.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eMOM website users | – | Other: eMOMAny woman who visits the "research" tab on the eMOM website will see an invitation to participate in a research study about the impact of the website on her bladder and bowel symptoms. Women may use the intervention (the website) regardless of whether they opt to participate in the research study. The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- While eMOM will be promoted specifically for older women, women of any age may access the program and participate in the study if they so choose.
Key inclusion criteria (4 listed)
- be able to access the eMOM website via internet
- must be able to speak and read English
- at least 18 years old
- female.
Key exclusion criteria (2 listed)
- no access to internet
- no email address
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 |
|---|---|---|
| eMOMAlso: Mind Over Matter: Healthy Bowels, Healthy Bladder" (MOM)The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence. | Other | eMOM website users |
Primary outcome
Response on global perception of improvement (GPI) tool at 4 months
Time frame: 4 months
Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement. Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse
11 secondary outcomes
Change in the response of Global patient satisfaction question (PSQ)
Time frame: 1 month, 4 months, 6 months
Change in patient estimated percent improvement (EPI)
Time frame: 1 month, 4 months, 6 months
Change in response on global perception of improvement (GPI) at 1 month and 6 months
Time frame: 1 month, 6 month
Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
Time frame: Baseline, 1 month, 4 month, 6 month
Differences in scores of the St. Mark's Incontinence Scale (aka Vaizey)
Time frame: baseline, 1 month, 4 month, 6 month
Self-reported behavior changes: change in the frequency of pelvic floor muscle exercises
Time frame: baseline, 1 month, 4 month, 6 month
Self-reported behavior changes: change in fluid intake
Time frame: baseline, 1 month, 4 month, 6 month
Self-reported behavior changes: change in fiber intake
Time frame: baseline, 1 month, 4 month, 6 month
Self-reported coping changes: change in types of pad used
Time frame: baseline, 1 month, 4 month, 6 month
Self-reported coping changes: change in number of pads used
Time frame: baseline, 1 month, 4 month, 6 month
Self-reported changes: change in the money-spent on buying products to manage their incontinence
Time frame: baseline, 1 month, 4 month, 6 month
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.
- Individual participant dataSharing planned: No
Related trials for Incontinence, Urinary
Active, not recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Bladder Exstrophy
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
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
UW-Madison Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incontinence, Urinary and Incontinence Bowel, 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 4 inclusion and 2 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?
Response on global perception of improvement (GPI) tool at 4 months (time frame: 4 months). 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 22 Aug 2025.