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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Stanford Pelvic Health Center
RECRUITING
Redwood City
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: Patient Engagement Tool (PET)
Participants will use the PET weekly for 12 weeks
No_intervention: Usual Care
Usual Clinic Follow up every 6 weeks for 12 weeks
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Stanford University

This content was sourced from clinicaltrials.gov