Improving Overactive Bladder Treatment Access and Adherence

Recruiting now · Not applicable

Conditions studied: Overactive Bladder Syndrome, Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT06094543

Run by

Stanford University

People needed

30

Starts

2024-11-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Stanford Pelvic Health Center — Redwood City, California, United States (enrolling)

Full record on ClinicalTrials.gov

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