Improving Overactive Bladder Treatment Access and Adherence

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

Conditions
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Overactive Bladder Syndrome, Urinary Incontinence

Intervention / Treatment
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* Behavioral: Patient Engagement Tool


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Engagement Tool (PET)<br>Participants will use the PET weekly for 12 weeks | Behavioral: Patient Engagement Tool<br>* 8 week daily patient education and engagement tool<br>|
| No Intervention: Usual Care<br>Usual Clinic Follow up every 6 weeks for 12 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability and Engagement | Usability, engagement, Patient engagement tool reliability/accessibility (technical issues) | 12 weeks | 
| OAB knowledge | Knowledge regarding OAB condition and therapy | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy adherence |  | 12 weeks | 
| OAB management satisfaction |  | 12 weeks | 
| Change in symptom severity |  | 12 weeks | 
| Patient centeredness |  | 12 weeks | 
| Patient Global Impression of Improvement (PGI-I) | PGI-I | 12 weeks |