Improving Overactive Bladder Treatment Access and Adherence

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT06094543
Status
Recruiting
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Conditions

  • Overactive Bladder Syndrome
  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Patient Engagement Tool — BEHAVIORAL
    8 week daily patient education and engagement tool

Study Details

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 Dates

Start date
Nov 1, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patient Engagement Tool (PET)
    Participants will use the PET weekly for 12 weeks
  • No Intervention: Usual Care
    Usual Clinic Follow up every 6 weeks for 12 weeks

Primary Outcome Measure

Systems Usability Scale (SUS) [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Pelvic Health CenterRedwood CityCalifornia94062
Ekene Enemchukwu, MD, MPH
[email protected]
650-723-1867
Kristine Talavera
[email protected]
650-723-1867

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