Cyclic Versus Continuous Sacral Neuromodulation for LUTS (NCT06170450) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cyclic Versus Continuous Sacral Neuromodulation for LUTS
United States50 participantsStarted 2024-04-15
Plain-language summary
This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Change in ICIQ-OAB-QoL score
Timeframe: Baseline, 12 months post-operatively
Trial details
NCT IDNCT06170450
SponsorUniversity Hospitals Cleveland Medical Center