Improving Overactive Bladder Treatment Access and Adherence
- Conditions
- Urinary IncontinenceOveractive Bladder Syndrome
- Interventions
- Behavioral: Patient Engagement Tool
- Registration Number
- NCT06094543
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Engagement Tool (PET) Patient Engagement Tool Participants will use the PET weekly for 12 weeks
- Primary Outcome Measures
Name Time Method Usability and Engagement 12 weeks Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
OAB knowledge 12 weeks Knowledge regarding OAB condition and therapy
- Secondary Outcome Measures
Name Time Method Change in symptom severity 12 weeks Patient Global Impression of Improvement (PGI-I) 12 weeks PGI-I
OAB management satisfaction 12 weeks Therapy adherence 12 weeks Patient centeredness 12 weeks
Trial Locations
- Locations (1)
Stanford Pelvic Health Center
🇺🇸Redwood City, California, United States