Urinary IncontinencePRACTICALNCT04237753
Remote Access to Urinary Incontinence Treatment for Women Veterans
A study testing VA Video Connect and MyHealtheBladder in people with Urinary Incontinence, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- VA Video Connect and MyHealtheBladder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Apr 2020to 30 Jun 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women Veterans
- Urinary incontinence occurring at least monthly for 3 months
- Able to access daily internet via computer or mobile device
- Access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder
Who cannot join
- Unstable medical conditions that could contribute to incontinence (e.g., recent major hospitalization, planned major surgery, conditions that affect urine volume - hemoglobin A1c of 9.0, chronic kidney disease with planned dialysis within 3 months, as assessed by PI or Site PI)
- Unstable psychiatric conditions (e.g., psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
- Unstable housing situation
- Genitourinary cancer undergoing active treatment with chemotherapy or radiation
- Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, TBI, Dementia, and Stroke Survivors with limited mobility)
- New treatments for incontinence started in the prior 3 months or planned during the 6-month study duration, includes medications and/or surgery
- Three months post-partum
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans
This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.
Read the detailed description
This study represents a unique opportunity to improve access to treatments for urine leakage for women Veterans. This research study will examine the effects of two mobile health technologies on improving bladder symptoms, as part of a randomized clinical trial. The study includes 260 women Veterans recruited from 3 sites: the Birmingham VAMC, the Atlanta VAHCS, and the Durham VAMC (86 per site). Women will receive first-line treatments for urine leakage through randomization to one of two delivery methods for direct treatment: (1) a web-based mobile health application that delivers content daily for 8 weeks compared to (2) a single video session delivered by VA Video Connect. At 8-weeks, women who do not have improved symptoms will have the ability to continue the treatment or receive an initial or booster video session. The investigators will measure bladder symptoms (3 questions by self-report over the phone or via survey) at baseline, 8-weeks, 12-weeks, and 6-months. Additionally, the investigators will interview 54 women Veterans and 12 providers to learn about their experiences with the technologies using 1:1 telephone interviews at 12-weeks. The findings from this study will inform the best technology to improve access for bladder leakage among women Veterans across a wider array of VHA facilities.
- Conditions
- Urinary Incontinence
- Being tested
- VA Video Connect, MyHealtheBladder
- Keywords
- women's health, Veterans, telemedicine, urinary incontinence, overactive urinary bladder, urinary bladder diseases, stress urinary incontinence, urge urinary incontinence, health education
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA Video ConnectBehavioural
Also called Telehealth visit with Continence Provider
Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
MyHealtheBladderBehavioural
Also called Mobile health bladder education
Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
| Study group | Role | What they receive |
|---|---|---|
| MyHealthebladder | Active comparator | Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage Receives: Behavioral: MyHealtheBladder |
| VA Video Connect | Active comparator | Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage Receives: Behavioral: VA Video Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity
Measured: baseline to 12 weeks
Secondary outcomes (4)
Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)
Overactive bladder symptom severity questionnaire, range 0-12, higher scores represent greater symptoms severity
Measured: baseline to 12-weeks
Global Rating of Patient Satisfaction
Patient satisfaction question (PSQ) - 3 categories of response (highly satisfied, satisfied, not satisfied)
Measured: 12-weeks
Self-reported Pelvic floor muscle exercise adherence
Adherence to pelvic floor muscle exercises reported as exercises per day completed over each week. Adherence defined as 80% of days with exercises completed over 12-week intervention period.
Measured: 12-weeks
Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity, longer term outcome
Measured: baseline to 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start6 Apr 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with adaptive trial design. Randomization will first involve treatment with one of two delivery methods: (1) a web-based mobile health application or (2) a single video session. For women who do not improve (SMART design), they will receive a first or second video session.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alayne D Markland, DO MSc, Principal investigator, Birmingham VA Medical Center, Birmingham, ALElizabeth Camille Vaughan, MD MS, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GASusan N. Hastings, MD MHSc, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237753
- Sponsor's protocol ID
- IIR 18-266
- Acronym
- PRACTICAL
- Status last verified
- Jul 2025
- First submitted
- 31 Dec 2019
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For purposes of this study, all data will be stripped of all patient identifiers and each participant will be given a unique identifier for the study. Participant records will be stored in a locked cabinet in a locked office and will be accessible only to the Principal Investigator, Nurse Practitioner delivering the intervention, Research Coordinator, and Site PI's (Markland, Vaughan, and Goldstein) and co-investigators per site-PI's guidance. Computer-based records will be maintained through the Veteran's Administration Computerized Patient Record System (CPRS), a secure network with password protection. A separate tracking database with participant identifiers that provide a link to the unique study IDs will be stored on a secure VA research server at each study site. Only deidentified data will be entered into the Redcap database by study personnel who are credentialed at the Birmingham VAMC through the research office.
Publications
Markland 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 40956581Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598Markland AD, Vaughan CP, Goldstein KM, Hastings SN, Kelly U, Beasley TM, Boyd EM, Zubkoff L, Burgio KL. Optimizing remote access to urinary incontinence treatments for women veterans (PRACTICAL): Study protocol for a pragmatic clinical trial comparing two virtual care options. Contemp Clin Trials. 2023 Oct;133:107328. doi: 10.1016/j.cct.2023.107328. Epub 2023 Sep 1.
PubMed 37659594
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans
- ClinicalTrials.gov ID
- NCT04237753
- Acronym / sponsor ID
- PRACTICAL / IIR 18-266
- Conditions
- Urinary Incontinence
- Keywords
- women's health, Veterans, telemedicine, urinary incontinence, overactive urinary bladder, urinary bladder diseases, stress urinary incontinence, urge urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Jan 2020 (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 study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.
Detailed description
This study represents a unique opportunity to improve access to treatments for urine leakage for women Veterans. This research study will examine the effects of two mobile health technologies on improving bladder symptoms, as part of a randomized clinical trial. The study includes 260 women Veterans recruited from 3 sites: the Birmingham VAMC, the Atlanta VAHCS, and the Durham VAMC (86 per site). Women will receive first-line treatments for urine leakage through randomization to one of two delivery methods for direct treatment: (1) a web-based mobile health application that delivers content daily for 8 weeks compared to (2) a single video session delivered by VA Video Connect. At 8-weeks, women who do not have improved symptoms will have the ability to continue the treatment or receive an initial or booster video session. The investigators will measure bladder symptoms (3 questions by self-report over the phone or via survey) at baseline, 8-weeks, 12-weeks, and 6-months. Additionally, the investigators will interview 54 women Veterans and 12 providers to learn about their experiences with the technologies using 1:1 telephone interviews at 12-weeks. The findings from this study will inform the best technology to improve access for bladder leakage among women Veterans across a wider array of VHA facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with adaptive trial design. Randomization will first involve treatment with one of two delivery methods: (1) a web-based mobile health application or (2) a single video session. For women who do not improve (SMART design), they will receive a first or second video session.
| Arm | Type | Receives |
|---|---|---|
| MyHealthebladder | Active comparator | Behavioral: MyHealtheBladderDaily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage |
| VA Video Connect | Active comparator | Behavioral: VA Video ConnectRemote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women Veterans
- Urinary incontinence occurring at least monthly for 3 months
- Able to access daily internet via computer or mobile device
- Access to personal email for MyHealtheBladder and VA Video Connect visit initiation and reminder
Key exclusion criteria (7 listed)
- Unstable medical conditions that could contribute to incontinence (e.g., recent major hospitalization, planned major surgery, conditions that affect urine volume - hemoglobin A1c of 9.0, chronic kidney disease with planned dialysis within 3 months, as assessed by PI or Site PI)
- Unstable psychiatric conditions (e.g., psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
- Unstable housing situation
- Genitourinary cancer undergoing active treatment with chemotherapy or radiation
- Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, TBI, Dementia, and Stroke Survivors with limited mobility)
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 |
|---|---|---|
| VA Video ConnectAlso: Telehealth visit with Continence ProviderRemote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage | Behavioural | VA Video Connect |
| MyHealtheBladderAlso: Mobile health bladder educationDaily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage | Behavioural | MyHealthebladder |
Primary outcome
Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: baseline to 12 weeks
Urinary incontinence severity questionnaire, range 0-21, higher scores represent greater symptom severity
4 secondary outcomes
Change International Consultation on Incontinence Modular Questionnaire (ICIQ)-Overactive Bladder (OAB)
Time frame: baseline to 12-weeks
Global Rating of Patient Satisfaction
Time frame: 12-weeks
Self-reported Pelvic floor muscle exercise adherence
Time frame: 12-weeks
Change in International Consultation on Incontinence Modular Questionnaire (ICIQ)- Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: baseline to 24-weeks
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 30 Jul 2025.
- Derived from this study: 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.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
- Derived from this study: PubMed 37659594Markland AD, Vaughan CP, Goldstein KM, Hastings SN, Kelly U, Beasley TM, Boyd EM, Zubkoff L, Burgio KL. Optimizing remote access to urinary incontinence treatments for women veterans (PRACTICAL): Study protocol for a pragmatic clinical trial comparing two virtual care options. Contemp Clin Trials. 2023 Oct;133:107328. doi: 10.1016/j.cct.2023.107328. Epub 2023 Sep 1.
- Individual participant dataSharing planned: Yes. For purposes of this study, all data will be stripped of all patient identifiers and each participant will be given a unique identifier for the study. Participant records will be stored in a locked cabinet in a locked office and will be accessible only to the Principal Investigator, Nurse Practitioner delivering the intervention, Research Coordinator, and Site PI's (Markland, Vaughan, and Goldstein) and co-investigators per site-PI's guidance. Computer-based records will be maintained through the Veteran's Administration Computerized Patient Record System (CPRS), a secure network with password protection. A separate tracking database with participant identifiers that provide a link to the unique study IDs will be stored on a secure VA research server at each study site. Only deidentified data will be entered into the Redcap database by study personnel who are credentialed at the Birmingham VAMC through the research office.
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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
Birmingham VA Medical Center, Birmingham, AL
Elizabeth Camille Vaughan, MD MS principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Susan N. Hastings, MD MHSc principal investigator
Durham VA Medical Center, Durham, NC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA Video Connect and MyHealtheBladder in people with Urinary Incontinence, run by VA Office of Research and Development 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 7 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 30 Jul 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?
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?
Change in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) (time frame: baseline to 12 weeks). 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 NCT04237753, which also lists 4 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 30 Jul 2025.