Improving Overactive Bladder Treatment Access and Adherence

Stanford University

Status

Enrolling

Conditions

Urinary Incontinence

Overactive Bladder Syndrome

Treatments

Behavioral: Patient Engagement Tool

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06094543

72487

K23DK131315-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)