Improving Overactive Bladder Treatment Access and Adherence
NCT06094543 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-11-26
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.
Conditions
- Overactive Bladder Syndrome
- Urinary Incontinence
Interventions
- BEHAVIORAL
-
Patient Engagement Tool
8 week daily patient education and engagement tool
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-01
- Primary Completion
- 2026-08-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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