Status:
RECRUITING
Improving Overactive Bladder Treatment Access and Adherence
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Overactive Bladder Syndrome
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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 signifi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06094543
Start Date
November 1 2024
End Date
December 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
Stanford Pelvic Health Center
Redwood City, California, United States, 94062