Overactive Bladder Syndrome, Urinary Incontinence
Conditions
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.
Interventions
BEHAVIORALPatient Engagement Tool
8 week daily patient education and engagement tool
Sponsors
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systems Usability Scale (SUS) | 12 weeks | Usability, engagement, Patient engagement tool reliability/accessibility (technical issues) |
| Bladder Health Knowledge, Attitudes, and Beliefs (KAB) | 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
| Measure | Time frame | Description |
|---|---|---|
| Therapy adherence | 12 weeks | — |
| Global Perceptions and Satisfaction with Treatment (LURN) | 12 weeks | OAB management satisfaction |
| ICIQ-UI & ICIQ-OAB Combined Questionnaire | 12 weeks | Will be used to assess change in symptom severity from baseline, 4 weeks and at 12 weeks |
| Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS) | 12 weeks | A validated patient-reported outcome measure developed by the NIH PROMIS initiative. The Self-Efficacy for Managing Chronic Conditions - Managing Symptoms subdomain was modified to assess a patient's confidence in their ability to monitor and manage bothersome symptoms related to chronic urinary incontinence and overactive bladder (OAB). It evaluates perceived ability to recognize symptom triggers, implement behavioral or lifestyle adjustments, and manage urinary urgency, frequency, or leakage in daily life. Higher scores indicate stronger self-efficacy, which has been associated with better adherence to treatment strategies, such as bladder training, fluid management, and pelvic floor exercises, in patients with OAB and incontinence. Each item is scored on a 5-point Likert scale with higher scores indicating greater self-efficacy. It is widely used in both clinical and research settings to assess readiness for self-management and tailor interventions accordingly. |
Countries
United States
Outcome results
None listed