Urinary IncontinencePURSUITNCT05438849
Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans
An observational study of Urinary Incontinence, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Mobile Health Application focused on behavioral treatments to treat urinary incontinence and Practice Facilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,214 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2022to 30 Nov 2026
- Phase
- Observational
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.
Who may be able to join
- Veteran
- English-speaking, community-dwelling women Veterans
- Diagnosis of UI (all types)
- Access to the internet via a mobile device or computer
Who cannot join
- Women Veterans who are currently pregnant or less than 12 weeks postpartum
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham VA Healthcare System
Birmingham, Alabama, 35233
Atlanta VA Health Care System
Decatur, Georgia, 30033
About this study
Official title: Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment
The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.
Read the detailed description
PURSUIT aims to recruit 62 practices to participate in the trial implementation at 50 practices. Specifically, Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. The project will focus on VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited through connections with local women's health providers. The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.
- Conditions
- Urinary Incontinence
- Being tested
- Mobile Health Application focused on behavioral treatments to treat urinary incontinence, Practice Facilitation
- Keywords
- women, Veterans, behavioral treatment, primary care
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Application focused on behavioral treatments to treat urinary incontinenceBehavioural
Also called MyHealtheBladder
Mobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans
Practice FacilitationCombination product
Also called Practice facilitation toolkit
The toolkit has 4 components: (1) Practice Facilitation Visits, (2) Mobile-health or mHealth Application Training (MAT) training, (3) Access and education on the Data Dashboard, and (4) Health information technology (HIT) assistance.
| Study group | Role | What they receive |
|---|---|---|
| Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA) | This project will include English-speaking, community-dwelling women Veterans 20 years or older with a diagnosis of UI (all types) and access to the internet via a mobile device or computer. Women Veterans who are currently pregnant or less than 12 weeks postpartum will be excluded. PURSUIT utilizes a mobile health application, called MyHealtheBladder, to connect patients with nonsurgical treatment options. Receives: Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinence | |
| Health care providers in community-based outpatient clinics in VISN-7 of the the VHA | Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited. Receives: Combination Product: Practice Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence (UI) screening rates
This will include measuring changes, over time, in UI diagnoses for women Veterans. These changes will be measured by pulling data on UI ICD-9 and ICD-10 codes collected via the program's clinical data dashboard.
Measured: Baseline and 6 months post-Baseline
Change, over time, in usage of the provider clinical data dashboard
This will include capturing the unique number of clinic site "champions" (i.e. designated women's health provider) who engage with this program's clinical data dashboard. Dashboard engagement will be measured as the number of unique site champions who use the dashboard divided by the total number of site champions involved in this program.
Measured: Baseline and 6 months post-Baseline
Secondary outcomes (5)
Enrollment rates of women Veterans for MyHealtheBladder
Women receiving behavioral urinary incontinence treatment on MyHealtheBladder
Measured: 2-, 4-, and 6-months post-Baseline
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
4-item tool to measure UI symptoms, scored on scale from 0-21 with a higher score indicating worse symptoms
Measured: Baseline and 2-months post-Baseline
Pelvic Floor Muscle Exercise (PFME) Adherence
2-item questionnaire to explore adherence to completing PFMEs
Measured: 2-months post-Baseline
System Usability Scale
10-item questionnaire, using 5-point Likert scale, to gauge the usability of MHB. Scoring range is 0-100 with a higher score indicating the system is more usable,
Measured: 2-months post-Baseline
Satisfaction and Perception of Improvement
3-item tool for feedback on participant satisfaction and perceived symptom improvement
Measured: 2-months post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Nov 2022
- Primary completion21 Nov 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Alayne D. Markland, University of Alabama at Birmingham
- Investigators
- Alayne D Markland, DO, MSc, Principal investigator, UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , ALLisa Zubkoff, PhD, Principal investigator, University of Alabama at Birmingham, Birmingham, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438849
- Sponsor's protocol ID
- IRB-300009637 (1658917-2)
- Other IDs
- U18HS028736
- Acronym
- PURSUIT
- Status last verified
- Aug 2026
- First submitted
- 25 May 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goode PS, Markland AD, Echt KV, Slay L, Barnacastle S, Hale G, Wright MK, Lane TR, Burgio KL. A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder. Neurourol Urodyn. 2020 Jan;39(1):432-439. doi: 10.1002/nau.24226. Epub 2019 Nov 27.
PubMed 31774200Markland AD, Goldstein KM, Beasley TM, Boyd EM, Zubkoff L, Kelly UA, Burgio KL, Vaughan CP. Remote Access to Urinary Incontinence Treatments for Women Veterans: The PRACTICAL Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532111. doi: 10.1001/jamanetworkopen.2025.32111.
PubMed 40956581
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment
- ClinicalTrials.gov ID
- NCT05438849
- Acronym / sponsor ID
- PURSUIT / IRB-300009637 (1658917-2)
- Conditions
- Urinary Incontinence
- Keywords
- women, Veterans, behavioral treatment, primary care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,214 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Jun 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.
The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.
Detailed description
PURSUIT aims to recruit 62 practices to participate in the trial implementation at 50 practices. Specifically, Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. The project will focus on VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited through connections with local women's health providers. The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA) | – | Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinenceThis project will include English-speaking, community-dwelling women Veterans 20 years or older with a diagnosis of UI (all types) and access to the internet via a mobile device or computer. Women Veterans who are currently pregnant or less than 12 weeks postpartum will be excluded. PURSUIT utilizes a mobile health application, called MyHealtheBladder, to connect patients with nonsurgical treatment options. |
| Health care providers in community-based outpatient clinics in VISN-7 of the the VHA | – | Combination Product: Practice FacilitationCommunity-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.
Key inclusion criteria (4 listed)
- Veteran
- English-speaking, community-dwelling women Veterans
- Diagnosis of UI (all types)
- Access to the internet via a mobile device or computer
Key exclusion criteria (1 listed)
- Women Veterans who are currently pregnant or less than 12 weeks postpartum
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 |
|---|---|---|
| Mobile Health Application focused on behavioral treatments to treat urinary incontinenceAlso: MyHealtheBladderMobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans | Behavioural | Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA) |
| Practice FacilitationAlso: Practice facilitation toolkitThe toolkit has 4 components: (1) Practice Facilitation Visits, (2) Mobile-health or mHealth Application Training (MAT) training, (3) Access and education on the Data Dashboard, and (4) Health information technology (HIT) assistance. | Combination product | Health care providers in community-based outpatient clinics in VISN-7 of the the VHA |
Primary outcome
Urinary incontinence (UI) screening rates
Time frame: Baseline and 6 months post-Baseline
This will include measuring changes, over time, in UI diagnoses for women Veterans. These changes will be measured by pulling data on UI ICD-9 and ICD-10 codes collected via the program's clinical data dashboard.
Change, over time, in usage of the provider clinical data dashboard
Time frame: Baseline and 6 months post-Baseline
This will include capturing the unique number of clinic site "champions" (i.e. designated women's health provider) who engage with this program's clinical data dashboard. Dashboard engagement will be measured as the number of unique site champions who use the dashboard divided by the total number of site champions involved in this program.
5 secondary outcomes
Enrollment rates of women Veterans for MyHealtheBladder
Time frame: 2-, 4-, and 6-months post-Baseline
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline and 2-months post-Baseline
Pelvic Floor Muscle Exercise (PFME) Adherence
Time frame: 2-months post-Baseline
System Usability Scale
Time frame: 2-months post-Baseline
Satisfaction and Perception of Improvement
Time frame: 2-months post-Baseline
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 31 Aug 2026.
- Background: PubMed 31774200Goode PS, Markland AD, Echt KV, Slay L, Barnacastle S, Hale G, Wright MK, Lane TR, Burgio KL. A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder. Neurourol Urodyn. 2020 Jan;39(1):432-439. doi: 10.1002/nau.24226. Epub 2019 Nov 27.
- Background: PubMed 40956581Markland AD, Goldstein KM, Beasley TM, Boyd EM, Zubkoff L, Kelly UA, Burgio KL, Vaughan CP. Remote Access to Urinary Incontinence Treatments for Women Veterans: The PRACTICAL Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532111. doi: 10.1001/jamanetworkopen.2025.32111.
- Individual participant dataSharing planned: Undecided
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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.
Alayne D Markland, DO, MSc principal investigator
UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , AL
Lisa Zubkoff, PhD principal investigator
University of Alabama at Birmingham, Birmingham, AL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by University of Alabama at Birmingham at 2 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Urinary incontinence (UI) screening rates (time frame: Baseline and 6 months post-Baseline). 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?
On the ClinicalTrials.gov record for NCT05438849, which also lists 2 linked publications.
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 31 Aug 2026.