An interventional study of Patient Engagement Tool in Overactive Bladder Syndrome and Urinary Incontinence, sponsored by Stanford University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use the PET weekly for 12 weeks
Behavioral: Patient Engagement Tool
Usual Clinic Follow up every 6 weeks for 12 weeks
8 week daily patient education and engagement tool
Systems Usability Scale (SUS)
Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
Time frame: 12 weeks
Bladder Health Knowledge, Attitudes, and Beliefs (KAB)
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.
Time frame: 12 weeks
Therapy adherence
Time frame: 12 weeks
Global Perceptions and Satisfaction with Treatment (LURN)
OAB management satisfaction
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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