Improving Overactive Bladder Treatment Access and Adherence

NCT ID: NCT06094543

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-12-31

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.

Conditions

Overactive Bladder Syndrome; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patient Engagement Tool (PET)

Participants will use the PET weekly for 12 weeks

Group Type: EXPERIMENTAL

Patient Engagement Tool

Intervention Type: BEHAVIORAL

8 week daily patient education and engagement tool

Usual Care

Usual Clinic Follow up every 6 weeks for 12 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient Engagement Tool

8 week daily patient education and engagement tool

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Ekene Enemchukwu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Pelvic Health Center

Redwood City, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Ekene Enemchukwu, MD, MPH

Role: primary

oab.matters@stanford.edu

650-723-1867

Kristine Talavera

Role: backup

oab.matters@stanford.edu

650-723-1867

Other Identifiers

72487

Identifier Type: -

Identifier Source: org_study_id