Improving Overactive Bladder Treatment Access and Adherence

NCT06094543 | Recruiting DMC

• 1 other identifier: 72487
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Systems Usability Scale (SUS)

  Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)

  12 weeks

• Bladder Health Knowledge, Attitudes, and Beliefs (KAB)

  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.

  12 weeks

Secondary Outcomes (4)

• Therapy adherence

  12 weeks

• Global Perceptions and Satisfaction with Treatment (LURN)

  12 weeks

• ICIQ-UI & ICIQ-OAB Combined Questionnaire

  12 weeks

• Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS)

  12 weeks

Study Arms (2)

Patient Engagement Tool (PET)

EXPERIMENTAL

Participants will use the PET weekly for 12 weeks

Behavioral: Patient Engagement Tool

Usual Care

NO INTERVENTION

Usual Clinic Follow up every 6 weeks for 12 weeks

Interventions

Patient Engagement Tool BEHAVIORAL

8 week daily patient education and engagement tool

Patient Engagement Tool (PET)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford Pelvic Health Center

Redwood City, California, 94062, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)