NCT06094543 Improving Overactive Bladder Treatment Access and Adherence
| NCT ID | NCT06094543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Overactive Bladder Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-11-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)
Frequently Asked Questions
Who can join the NCT06094543 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Overactive Bladder Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06094543 currently recruiting?
Yes, NCT06094543 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT06094543 trial being conducted?
This trial is being conducted at Redwood City, United States.
Who is sponsoring the NCT06094543 clinical trial?
NCT06094543 is sponsored by Stanford University. The trial plans to enroll 30 participants.