Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170450
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-12-06
Brief Title:
Cyclic Versus Continuous Sacral Neuromodulation for LUTS
Sponsor:
David Sheyn
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
CYclic Versus Continuous Sacral Modulation for LowEr Urinary Tract Symptoms a Prospective Randomized Controlled Trial CYCLE Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 for patients with refractory OAB who have failed treatment with behavioral modification and medication SNM settings are typically selected based on discussion between the patient and device representative There is a paucity of rigorous data assessing optimal SNM stimulation programming for symptomatic improvement
This will be a prospective randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation SNM in patients undergoing SNM for OAB
Patients age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM either stage I leadtemporary battery placement or office peripheral nerve evaluation will be approached by study personnel during their clinic visit or by a phone call to determine if they are interested in participating in the programming study
Patients interested in participating will provide written informed consent After informed consent is obtained a baseline evaluation will be performed This includes history 3-day voiding diary voiding episodes nocturia episodes urge incontinence episodes24h urinalysis urine culture if indicated post void residuals and symptom assessments using questionnaires
Only those with successful trial and eligible interested in permanent SNM placement will participate in this trial Randomization will occur after stage 2 full permanent implantation when the neuromodulator is being programmed in the recovery room Patients will be randomly assigned to either continuous stimulation or cyclic stimulation
Patients will then be followed with clinical evaluation and questionnaires repeated at 1 month 6 months 12 months 3 years and 5 years post-op
This will be a prospective randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation SNM in patients undergoing SNM for OAB
Patients age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM either stage I leadtemporary battery placement or office peripheral nerve evaluation will be approached by study personnel during their clinic visit or by a phone call to determine if they are interested in participating in the programming study
Patients interested in participating will provide written informed consent After informed consent is obtained a baseline evaluation will be performed This includes history 3-day voiding diary voiding episodes nocturia episodes urge incontinence episodes24h urinalysis urine culture if indicated post void residuals and symptom assessments using questionnaires
Only those with successful trial and eligible interested in permanent SNM placement will participate in this trial Randomization will occur after stage 2 full permanent implantation when the neuromodulator is being programmed in the recovery room Patients will be randomly assigned to either continuous stimulation or cyclic stimulation
Patients will then be followed with clinical evaluation and questionnaires repeated at 1 month 6 months 12 months 3 years and 5 years post-op
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None