Recruiting

Patient-Centered Tool

Sponsor:

Stanford University

Code:

NCT06094543

Conditions

Overactive Bladder Syndrome

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Patient Engagement Tool

Study Details

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 ID

NCT06094543

Start date

Nov 1, 2024

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Patient Engagement Tool

8 week daily patient education and engagement tool

Primary outcome measure

  • Systems Usability Scale (SUS) [ Time Frame: 12 weeks ]
  • Bladder Health Knowledge, Attitudes, and Beliefs (KAB) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Stanford Pelvic Health Center

Recruiting

Redwood City, California, United States, 94062

Contacts

More Information

Sponsor

Stanford University

Last update posted

Jul 21, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-07-21.