Improving Overactive Bladder Treatment Access and Adherence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Engagement Tool.
- Who it may be relevant to
- Registry conditions: Overactive Bladder Syndrome, Urinary Incontinence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions
Overview
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
- Behavioral Patient Engagement Tool
8 week daily patient education and engagement tool
Primary outcome measures
- Systems Usability Scale (SUS) [Time frame: 12 weeks]
- Bladder Health Knowledge, Attitudes, and Beliefs (KAB) [Time frame: 12 weeks]
Secondary outcome measures (4)
- Therapy adherence [Time frame: 12 weeks]
- Global Perceptions and Satisfaction with Treatment (LURN) [Time frame: 12 weeks]
- ICIQ-UI & ICIQ-OAB Combined Questionnaire [Time frame: 12 weeks]
- Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS) [Time frame: 12 weeks]
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford Pelvic Health Center — Redwood City
Identifiers
NCT: NCT06094543 · 72487