Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder Syndrome
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Systems Usability Scale (SUS)
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Ekene Enemchukwu
Associate Professor
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Systems Usability Scale (SUS)
Time Frame: 12 weeks
Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
Bladder Health Knowledge, Attitudes, and Beliefs (KAB)
Time Frame: 12 weeks
Will assess knowledge about bladder health 1. Knowledge: Awareness and understanding of normal bladder function, signs and symptoms of dysfunction (e.g., incontinence, urgency), and available treatment or prevention strategies. 2. Attitudes: Perceptions and feelings toward bladder health, such as embarrassment, stigma, or normalization of symptoms like leakage or urgency. 3. Beliefs: Individual or cultural beliefs about the causes, severity, and treatability of bladder problems, which may influence care-seeking behavior.
Secondary Outcomes
- Global Perceptions and Satisfaction with Treatment (LURN)(12 weeks)
- Therapy adherence(12 weeks)
- ICIQ-UI & ICIQ-OAB Combined Questionnaire(12 weeks)
- Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS)(12 weeks)