Overactive Bladder SyndromeNCT06094543
Improving Overactive Bladder Treatment Access and Adherence
A study testing Patient Engagement Tool in people with Overactive Bladder Syndrome and Urinary Incontinence, run by Stanford University at 1 site in United States.
Trial summary
Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. 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
- Overactive Bladder Syndrome, Urinary Incontinence
- What is being tested?
- Patient Engagement Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Dec 2027
- 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
- Female aged 18 years or older
- OAB symptoms for at least 3 months
- English/Spanish language skills and cognitive status sufficient to complete all study related materials
- Behavioral treatment naïve patients
- Previously treated OAB patients without supervised pelvic floor physical therapy or pharmacotherapy within 1 year
Who cannot join
- Post void residual urine > 150ml
- Confirmed diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
- Pregnant or breastfeeding patients
- Patients residing in a nursing home
- Comorbid neurological conditions, including spinal cord injury, progressive neurologic illnesses (e.g. Multiple Sclerosis, Parkinson's disease) or central nervous system disease (e.g. brain tumor, stroke)
- Stage 2 or greater pelvic organ prolapse
Show all 13Show fewer
- Any history of urethral stricture
- Any history of pelvic irradiation
- Any history of bladder malignancy
- Current symptomatic urinary tract infection (UTI), unresolved by the time of enrollment
- Hematuria without a clinical evaluation
- History or current use of indwelling urinary foley catheterization, suprapubic tube or intermittent catheterization
- Patients with UI treated with onabotulinumtoxinA, sacral neuromodulation, or percutaneous tibial nerve stimulation (third line therapies)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Pelvic Health Center
Redwood City, California, 94062
Ekene Enemchukwu, MD, MPH, 650-723-1867, oab.matters@stanford.edu
Kristine Talavera, 650-723-1867, oab.matters@stanford.edu
About this study
Official title: Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions
Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. OAB syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. Evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. Diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (QOL).3 However, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). In addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. Vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. Poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. This leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. The study aims to evaluate a tailored patient-centered tool to begin the treatment process.
- Conditions
- Overactive Bladder Syndrome, Urinary Incontinence
- Being tested
- Patient Engagement Tool
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Engagement ToolBehavioural
8 week daily patient education and engagement tool
| Study group | Role | What they receive |
|---|---|---|
| Patient Engagement Tool (PET) | Experimental | Participants will use the PET weekly for 12 weeks Receives: Behavioral: Patient Engagement Tool |
| Usual Care | No intervention | Usual Clinic Follow up every 6 weeks for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systems Usability Scale (SUS)
Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
Measured: 12 weeks
Bladder Health Knowledge, Attitudes, and Beliefs (KAB)
Will assess knowledge about bladder health
- Knowledge: Awareness and understanding of normal bladder function, signs and symptoms of dysfunction (e.g., incontinence, urgency), and available treatment or prevention strategies.
- Attitudes: Perceptions and feelings toward bladder health, such as embarrassment, stigma, or normalization of symptoms like leakage or urgency.
- Beliefs: Individual or cultural beliefs about the causes, severity, and treatability of bladder problems, which may influence care-seeking behavior.
Measured: 12 weeks
Secondary outcomes (4)
Therapy adherence
Measured: 12 weeks
Global Perceptions and Satisfaction with Treatment (LURN)
OAB management satisfaction
Measured: 12 weeks
ICIQ-UI & ICIQ-OAB Combined Questionnaire
Will be used to assess change in symptom severity from baseline, 4 weeks and at 12 weeks
Measured: 12 weeks
Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS)
A validated patient-reported outcome measure developed by the NIH PROMIS initiative.
The Self-Efficacy for Managing Chronic Conditions - Managing Symptoms subdomain was modified to assess a patient's confidence in their ability to monitor and manage bothersome symptoms related to chronic urinary incontinence and overactive bladder (OAB). It evaluates perceived ability to recognize symptom triggers, implement behavioral or lifestyle adjustments, and manage urinary urgency, frequency, or leakage in daily life.
Higher scores indicate stronger self-efficacy, which has been associated with better adherence to treatment strategies, such as bladder training, fluid management, and pelvic floor exercises, in patients with OAB and incontinence.
Each item is scored on a 5-point Likert scale with higher scores indicating greater self-efficacy. It is widely used in both clinical and research settings to assess readiness for self-management and tailor interventions accordingly.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekene Enemchukwu, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094543
- Sponsor's protocol ID
- 72487
- Status last verified
- Nov 2025
- First submitted
- 16 Oct 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions
- ClinicalTrials.gov ID
- NCT06094543
- Acronym / sponsor ID
- 72487
- Conditions
- Overactive Bladder Syndrome, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Oct 2023 (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.
Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. OAB syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. Evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. Diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (QOL).3 However, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). In addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. Vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. Poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. This leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. The study aims to evaluate a tailored patient-centered tool to begin the treatment process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Engagement Tool (PET) | Experimental | Behavioral: Patient Engagement ToolParticipants will use the PET weekly for 12 weeks |
| Usual Care | No intervention | –Usual Clinic Follow up every 6 weeks for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female aged 18 years or older
- OAB symptoms for at least 3 months
- English/Spanish language skills and cognitive status sufficient to complete all study related materials
- Behavioral treatment naïve patients
- Previously treated OAB patients without supervised pelvic floor physical therapy or pharmacotherapy within 1 year
Key exclusion criteria (13 listed)
- Post void residual urine > 150ml
- Confirmed diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
- Pregnant or breastfeeding patients
- Patients residing in a nursing home
- Comorbid neurological conditions, including spinal cord injury, progressive neurologic illnesses (e.g. Multiple Sclerosis, Parkinson's disease) or central nervous system disease (e.g. brain tumor, stroke)
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 |
|---|---|---|
| Patient Engagement Tool8 week daily patient education and engagement tool | Behavioural | Patient Engagement Tool (PET) |
Primary outcome
Systems Usability Scale (SUS)
Time frame: 12 weeks
Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
Bladder Health Knowledge, Attitudes, and Beliefs (KAB)
Time frame: 12 weeks
Will assess knowledge about bladder health 1. Knowledge: Awareness and understanding of normal bladder function, signs and symptoms of dysfunction (e.g., incontinence, urgency), and available treatment or prevention strategies. 2. Attitudes: Perceptions and feelings toward bladder health, such as embarrassment, stigma, or normalization of symptoms like leakage or urgency. 3. Beliefs: Individual or cultural beliefs about the causes, severity, and treatability of bladder problems, which may influence care-seeking behavior.
4 secondary outcomes
Therapy adherence
Time frame: 12 weeks
Global Perceptions and Satisfaction with Treatment (LURN)
Time frame: 12 weeks
ICIQ-UI & ICIQ-OAB Combined Questionnaire
Time frame: 12 weeks
Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS)
Time frame: 12 weeks
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Engagement Tool in people with Overactive Bladder Syndrome and Urinary Incontinence, run by Stanford University 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systems Usability Scale (SUS) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.