Status:
ACTIVE_NOT_RECRUITING
Cyclic Versus Continuous Sacral Neuromodulation for LUTS
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Northwestern University
University of Louisville
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.
Detailed Description
Overactive bladder (OAB) is characterized by urinary frequency, urgency, incontinence, and nocturia in the absence of other pathology. AUA guidelines recommend trial of sacral neuromodulation (SNM) fo...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older
- Female
- English Speaking
- Diagnosis of urinary urge incontinence or overactive bladder
- Meet criteria for and are planning permanent SNM (ie. successful stage I or office PNE trial of SNM with 50% or more reduction in UUI episodes)
- Willing and able to complete all study related items
Exclusion
- Patients less than 18 years of age
- Unable to provide consent
- Non-English speaking
- Relevant neurologic diseases (multiple sclerosis, Parkinson Disease, myasthenia gravis, - - - Charcot-Marie-Tooth disease, complete spinal cord injury)
- Current or prior bladder malignancy
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06170450
Start Date
April 15 2024
End Date
June 1 2030
Last Update
May 21 2025
Active Locations (3)
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1
University of Louisville
Louisville, Kentucky, United States, 40202
2
University Hospitals
Cleveland, Ohio, United States, 44106
3
MetroHealth
Cleveland, Ohio, United States, 44109