Improving Overactive Bladder Treatment Access and Adherence

Not Recruiting

Trial ID: NCT06094543

Purpose

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.

Official Title

Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions

Stanford Investigator(s)

Ekene Enemchukwu
Ekene Enemchukwu

Associate Professor of Urology and, by courtesy, of Obstetrics and Gynecology (Urogynecology)

Eligibility


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)

Intervention(s):

behavioral: Patient Engagement Tool

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ekene Enemchukwu, MD, MPH
650-723-1867