Urinary IncontinenceWI-INTUITNCT05664451
WI-INTUIT: Bridging Community Based Continence Promotion and Primary Care
A study testing UI-Assist and Partnership Building in people with Urinary Incontinence, run by Medical College of Wisconsin at 3 sites in United States.
Trial summary
This project seeks to determine whether primary care practices that receive supplemental partnership building implement UI-Assist with higher fidelity than practices that receive streamlined practice facilitation alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- UI-Assist and Partnership Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2022to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be 18 years or older and be assigned female at birth
- Practices must have and be willing to provide key data from electronic health records
- Practices willing to participate in partnership building activities (randomly allocated)
- Practices willing to work with a practice facilitator to implement UI-Assist in their practice
Who cannot join
- No additional exclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MetaStar, Inc.
Madison, Wisconsin, 53713
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kaiser Permanente
San Diego, California, 92110
About this study
Official title: Improving Nonsurgical Treatment of Urinary Incontinence Among Women in Primary Care in Wisconsin: Bridging Community-based Continence Promotion and Primary Care
This project seeks to determine whether primary care practices that receive supplemental partnership building implement UI-Assist with higher fidelity than practices that receive streamlined practice facilitation alone.
Read the detailed description
This quality improvement research project is one of five across the country funded by the Agency for Healthcare Research and Quality (AHRQ) through the EvidenceNOW Managing Urinary Incontinence initiative titled: "Improving Nonsurgical Treatment of Urinary Incontinence among women in Primary Care." The purpose of this national initiative is to identify implementation strategies that best support primary care practices in delivering high quality care for urinary incontinence. Components of high-quality care including screening, diagnosing, and offering non-surgical first-line treatments for urinary incontinence in women, all of which already occur in primary care.
The WI-INTUIT quality improvement project compares two implementation strategies to implement UI-Assist, an intervention to support primary care practices in increasing their rates of screening, diagnosing, and treating urinary incontinence in their adult female patients: (1) streamlined practice facilitation (SPF) and (2) streamlined practice facilitation in combination with partnership building (SPF+PB).
- Conditions
- Urinary Incontinence
- Being tested
- UI-Assist, Partnership Building
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UI-AssistBehavioural
To support primary care in implementing guideline-based care, it is helpful to distill interventions to their key components, such as the five major intervention steps for tobacco use and dependence (the "5 A's"). The 5 A's (Ask, Advise, Assess, Assist, Arrange) has been shown to help primary care providers implement clinical practice guidelines with minimal additional burden. The 5 A's can be similarly simplified for urinary incontinence (UI) screening and treatment to Ask (screen for UI); Advise (inform that effective nonsurgical treatments exist); and Assist (help patient get treatment with pharmacotherapy, referral to community classes, physiotherapy or urology / urogynecology).
Partnership BuildingOther
In addition to the strategies described above, those practices allocated to streamlined practice facilitation and partnership building will have facilitation and configurable solutions that engage community resources and enable coalition building. In addition to a practice facilitator, a partnership facilitator from the Wisconsin Institute for Healthy Aging (WIHA) will identify existing local community resources with which the practice may choose to partner. After initiating academic detailing, these practices will have further access to Drs. Brown and Neuner for ongoing consultation. An online learning community will also be created where information can be shared and exchanged throughout the duration of the project and beyond the maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| Streamlined Practice Facilitation (SPF) implementation of UI-Assist | Active comparator | Streamlined practice facilitation encompasses multiple well-established strategies from the Expert Recommendations for Implementing Change (ERIC) as field-tested in and updated after EvidenceNOW. To ensure the interventions and tools offered are consistent across practices, practice facilitators will receive training and support on UI-Assist, milestones, tracking tools for documenting changes made by sites, etc. according to a Practice Facilitation Training Manual and toolkit that will be built based on ones used for prior EvidenceNOW initiatives. Receives: Behavioral: UI-Assist |
| Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist | Experimental | In addition to streamlined practice facilitation, those practices allocated to Streamlined Practice Facilitation plus Partnership Building (SPF+PB) will have facilitation and configurable solutions that engage community resources and enable coalition building. In addition to a MetaStar practice facilitator, a partnership facilitator from the Wisconsin Institute for Healthy Aging (WIHA) will identify existing local community resources with which the practice may choose to partner. Receives: Behavioral: UI-Assist; Other: Partnership Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Screening Rates for Urinary Incontinence
Defined as the rate of eligible patients screened for urinary incontinence (UI) at preventive visits. Data on UI screening and patient eligibility will be ascertained through responses to a short post-visit patient survey. Patients will be asked five questions to determine if their healthcare team screened for and, if necessary, provided them with treatment options for UI. Preventive visits include visits classified as: a preventive visit, a physical exam, or a Medicare annual wellness visit.
Measured: 3 months, 10 months
Secondary outcomes (18)
Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
This 10-item survey measures symptoms, functioning, and quality-of-life for various chronic conditions and diseases. Two overall scores are calculated: a Global Physical Health Score and a Global Mental Health Score. Response options are on a 5-pt scale. Each score has a range of 0-20, 0 represents most severe mental and physical impairment, 20 represents the best state of health possible.
Measured: 10 months, 13 months
Differences in bowel leakage symptoms
This 4-item survey assesses patient experience with accidental bowel leakage in terms of frequency (Rarely, Sometimes, Weekly, Daily, I don't know), amount of leakage (Gas only, Small amount of stool, Moderate amount of stool, Large bowel movement, I don't know) and seeking care (Yes, No, I don't know).
Measured: 10 months, 13 months
Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Constipation
This 3-item scale measures patient's difficulty with passing bowel movements within the past 7 days. Question responses are Never, One day, 2-6 days, Once a day, More than once a day or Never, Rarely, Sometimes, Often, Always. Higher scores indicate patients have a greater difficulty with passing bowel movements.
Measured: 10 months, 13 months
Self-reported changes: changes in usage of urinary incontinence coping strategies
This item ascertains whether the individual has tried to use any urinary incontinence coping strategies "Have you tried any strategies to improve your urinary incontinence/ leakage?" Response options: "Yes, No, I don't know". The uptake in strategies between baseline and 90-day follow-up will be assessed.
Measured: 10 months, 13 months
Self-reported changes: change in money-spent on incontinence treatments
Self-reported changes: change in out-of-pocket costs of incontinence treatments to manage symptoms. This will be ascertained by asking participants how much money have they spent on products to manage their symptoms.
Measured: 10 months, 13 months
Self-reported changes: urinary incontinence treatments adopted
This item addresses which urinary incontinence treatment strategies the individual implemented "If yes, what strategies did you try? Please select all that apply." Response options: (1) Making changes to what you eat or drink; (2) Making changes to how often you urinate; (3) Wearing pads, panty liners, or disposable undergarments (diapers); (4) Doing pelvic floor muscle exercises (Kegels) on your own; (5) Doing pelvic floor muscle exercises (Kegels) with a therapist; (6) Using a medication; (7) Stopping a medication; (8) Using a pessary (something that sits inside the vagina to help with urine leakage); (9) Having a procedure (for example, injections to the bladder, electrical stimulation, or surgery); (10) Something else: ______
Measured: 10 months, 13 months
Self-reported changes: change in pad use
Self-reported changes: change in the number and type of pad(s) used
Measured: 10 months, 13 months
Global perception of improvement (GPI)
Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement.
This item asks patients if they feel their urinary incontinence has changed over the past 90 days. Participants are able to select one of the following options: very much better, much better, a little better, no change, a little worse, much worse, very much worse.
Measured: 13 months
Practice contextual factors - reach
This questionnaire collects practice-level demographic information including: setting, general patient demographic information, general provider-level information, practice patterns, and relationships with other health care systems.
Measured: 1 month
Difference in scores of the Change Process Capability Questionnaire (CPCQ) Strategies Scale
This validated instrument assesses practice systems ability to implement change by measuring attitudes and experience with implementation strategies in a Likert rating scale.
Each response to the CPCQ survey is coded so that 2=strongly positive, 1=positive, 0=neutral, -1=negative, and -2=strongly negative. The coded responses are summed to create a strategies score, with the score ranging from -28 to +28. More negative scores are associated with lower use of strategies and more positive scores are associated with higher use of strategies.
Measured: 1 month, 9 months
Organizational Readiness for Implementing Change
This 12-item survey measures how well employees at an organization feel they can implement the change in processes proposed by an intervention. Each of the 12-items is measured by a Likert scale (1=Disagree through 5=Agree). Responses are summed; higher scores indicate participants are more likely to initiate change, exert greater effort, and exhibit greater persistence; whereas, lower scores indicate the opposite.
Measured: 1 month, 9 months
Clinical Staff Questionnaire in the National Demonstration Project - Community knowledge
The community knowledge subset of the Clinical Staff Questionnaire, consists of four questions on a Likert scale (1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree). Scores on this subset will be summed and then averaged for each individual's response (score range: 1 to 5). Items will be reverse-scored when appropriate so that higher numbers reflect more positive ratings.
Measured: 1 month, 9 months
Clinical Staff Questionnaire in the National Demonstration Project - Practice adaptive reserve
The practice adaptive reserve subset of the Clinical Staff Questionnaire, consists of 23 questions on a Likert scale (1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree). Scores on this subset will be summed and then averaged for each individual's response (score range: 1 to 5). Items will be reverse-scored when appropriate so that higher numbers reflect practices' ability to make and sustain change.
Measured: 1 month, 9 months
Change in response to a single-item burnout measure
The single-item burnout measure, adapted from the Mini Z Burnout survey, assesses healthcare staff burnout. Responses are 1-5, with scores of 3 or higher defining high burnout.
Measured: 1 month, 9 months
Change in response to Urinary Incontinence Assist Project Practice Survey
All clinic staff members will be asked about their experience implementing the UI-Assist tool. The survey will ask individuals to rate various aspects of their clinic's prior experiences with urinary incontinence on a Likert scale (Not at all, slightly, somewhat, very, extremely). Individuals will be asked questions pertaining to the ease of incorporating UI-Assist into their project on a Likert scale, as well as questions pertaining to the perception of the project in their clinic on a Likert scale (1=strongly disagree through 7=strongly agree).
Measured: 6 months, 9 months, and 12 months
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: 10 months, 13 months
Differences in scores of Incontinence Impact Questionnaire (IIQ-7)
The Incontinence Impact Questionnaire - Short Form (IIQ-7) will be used to assess areas in a patient's life that may have been influenced or changed by their urinary incontinence. Patients are asked to select the response that best describes how much their activities, relationships, and feelings are being affected by urinary incontinence. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. A score <50 indicates good quality of life, between 50-70 indicates moderate quality of life, and >70 indicates poor quality of life.
Measured: 10 months, 13 months
Patients' health literacy level
Patients will be asked four questions to determine their health literacy level through the BRIEF - health literacy screening tool. Each item is worth 1 to 5 points depending on their response. Add the values for the four responses to get a total score, which can range from a minimum of 4 to a maximum to 20. A score of 4 - 12 (limited) indicates the patient is not able to read most low literacy health materials; will need repeated oral instructions; materials should be composed of illustrations or video tapes. Will need low literacy materials; may not be able to read a prescription label. A score of 13 - 16 (marginal) indicates the patient may need assistance; may struggle with patient education materials. A score of 17 - 20 (adequate) indicates the patient will be able to read and comprehend most patient education materials.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 May 2022
- Primary completion25 Apr 2025
- Study completionApr 2026 (estimated)
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 Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- MetaStar, Inc., Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Kathryn Flynn, Medical College of Wisconsin
- Investigators
- Joan Neuner, MD, MPH, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664451
- Sponsor's protocol ID
- 2021-1477
- Other IDs
- PRO00042157, 1U18HS028738-01
- Acronym
- WI-INTUIT
- Status last verified
- Jun 2025
- First submitted
- 7 Nov 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel UJ, Moureau MK, Neuner JM, Brown HW. Screening and Treating Urinary Incontinence in Primary Care: A Missed Opportunity. OBM Geriat. 2023;7(4):252. doi: 10.21926/obm.geriatr.2304252. Epub 2023 Oct 5.
PubMed 38567050
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nonsurgical Treatment of Urinary Incontinence Among Women in Primary Care in Wisconsin: Bridging Community-based Continence Promotion and Primary Care
- ClinicalTrials.gov ID
- NCT05664451
- Acronym / sponsor ID
- WI-INTUIT / 2021-1477
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- MetaStar, Inc., Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Dec 2022 (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.
This project seeks to determine whether primary care practices that receive supplemental partnership building implement UI-Assist with higher fidelity than practices that receive streamlined practice facilitation alone.
Detailed description
This quality improvement research project is one of five across the country funded by the Agency for Healthcare Research and Quality (AHRQ) through the EvidenceNOW Managing Urinary Incontinence initiative titled: "Improving Nonsurgical Treatment of Urinary Incontinence among women in Primary Care." The purpose of this national initiative is to identify implementation strategies that best support primary care practices in delivering high quality care for urinary incontinence. Components of high-quality care including screening, diagnosing, and offering non-surgical first-line treatments for urinary incontinence in women, all of which already occur in primary care.
The WI-INTUIT quality improvement project compares two implementation strategies to implement UI-Assist, an intervention to support primary care practices in increasing their rates of screening, diagnosing, and treating urinary incontinence in their adult female patients: (1) streamlined practice facilitation (SPF) and (2) streamlined practice facilitation in combination with partnership building (SPF+PB).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Streamlined Practice Facilitation (SPF) implementation of UI-Assist | Active comparator | Behavioral: UI-AssistStreamlined practice facilitation encompasses multiple well-established strategies from the Expert Recommendations for Implementing Change (ERIC) as field-tested in and updated after EvidenceNOW. To ensure the interventions and tools offered are consistent across practices, practice facilitators will receive training and support on UI-Assist, milestones, tracking tools for documenting changes made by sites, etc. according to a Practice Facilitation Training Manual and toolkit that will be built based on ones used for prior EvidenceNOW initiatives. |
| Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist | Experimental | Behavioral: UI-Assist, Other: Partnership BuildingIn addition to streamlined practice facilitation, those practices allocated to Streamlined Practice Facilitation plus Partnership Building (SPF+PB) will have facilitation and configurable solutions that engage community resources and enable coalition building. In addition to a MetaStar practice facilitator, a partnership facilitator from the Wisconsin Institute for Healthy Aging (WIHA) will identify existing local community resources with which the practice may choose to partner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be 18 years or older and be assigned female at birth
- Practices must have and be willing to provide key data from electronic health records
- Practices willing to participate in partnership building activities (randomly allocated)
- Practices willing to work with a practice facilitator to implement UI-Assist in their practice
Key exclusion criteria (1 listed)
- No additional exclusion criteria
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 |
|---|---|---|
| UI-AssistTo support primary care in implementing guideline-based care, it is helpful to distill interventions to their key components, such as the five major intervention steps for tobacco use and dependence (the "5 A's"). The 5 A's (Ask, Advise, Assess, Assist, Arrange) has been shown to help primary care providers implement clinical practice guidelines with minimal additional burden. The 5 A's can be similarly simplified for urinary incontinence (UI) screening and treatment to Ask (screen for UI); Advise (inform that effective nonsurgical treatments exist); and Assist (help patient get treatment with pharmacotherapy, referral to community classes, physiotherapy or urology / urogynecology). | Behavioural | Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist, Streamlined Practice Facilitation (SPF) implementation of UI-Assist |
| Partnership BuildingIn addition to the strategies described above, those practices allocated to streamlined practice facilitation and partnership building will have facilitation and configurable solutions that engage community resources and enable coalition building. In addition to a practice facilitator, a partnership facilitator from the Wisconsin Institute for Healthy Aging (WIHA) will identify existing local community resources with which the practice may choose to partner. After initiating academic detailing, these practices will have further access to Drs. Brown and Neuner for ongoing consultation. An online learning community will also be created where information can be shared and exchanged throughout the duration of the project and beyond the maintenance phase. | Other | Streamlined Practice Facilitation (SPF) + Partnership Building (PB) implementation of UI-Assist |
Primary outcome
Differences in Screening Rates for Urinary Incontinence
Time frame: 3 months, 10 months
Defined as the rate of eligible patients screened for urinary incontinence (UI) at preventive visits. Data on UI screening and patient eligibility will be ascertained through responses to a short post-visit patient survey. Patients will be asked five questions to determine if their healthcare team screened for and, if necessary, provided them with treatment options for UI. Preventive visits include visits classified as: a preventive visit, a physical exam, or a Medicare annual wellness visit.
18 secondary outcomes
Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
Time frame: 10 months, 13 months
Differences in bowel leakage symptoms
Time frame: 10 months, 13 months
Differences in scores on Patient-Reported Outcomes Measurement Information System (PROMIS) - Constipation
Time frame: 10 months, 13 months
Self-reported changes: changes in usage of urinary incontinence coping strategies
Time frame: 10 months, 13 months
Self-reported changes: change in money-spent on incontinence treatments
Time frame: 10 months, 13 months
Self-reported changes: urinary incontinence treatments adopted
Time frame: 10 months, 13 months
Self-reported changes: change in pad use
Time frame: 10 months, 13 months
Global perception of improvement (GPI)
Time frame: 13 months
Practice contextual factors - reach
Time frame: 1 month
Difference in scores of the Change Process Capability Questionnaire (CPCQ) Strategies Scale
Time frame: 1 month, 9 months
Organizational Readiness for Implementing Change
Time frame: 1 month, 9 months
Clinical Staff Questionnaire in the National Demonstration Project - Community knowledge
Time frame: 1 month, 9 months
Clinical Staff Questionnaire in the National Demonstration Project - Practice adaptive reserve
Time frame: 1 month, 9 months
Change in response to a single-item burnout measure
Time frame: 1 month, 9 months
Change in response to Urinary Incontinence Assist Project Practice Survey
Time frame: 6 months, 9 months, and 12 months
Differences in scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
Time frame: 10 months, 13 months
Differences in scores of Incontinence Impact Questionnaire (IIQ-7)
Time frame: 10 months, 13 months
Patients' health literacy level
Time frame: 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Results publication: PubMed 38567050Patel UJ, Moureau MK, Neuner JM, Brown HW. Screening and Treating Urinary Incontinence in Primary Care: A Missed Opportunity. OBM Geriat. 2023;7(4):252. doi: 10.21926/obm.geriatr.2304252. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
Joan Neuner, MD, MPH principal investigator
Medical College of Wisconsin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UI-Assist and Partnership Building in people with Urinary Incontinence, run by Medical College of Wisconsin at 3 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Differences in Screening Rates for Urinary Incontinence (time frame: 3 months, 10 months). 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 NCT05664451, 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 18 Jun 2025.