Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-28 @ 8:06 PM
Study NCT ID:
NCT06170450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2023-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclic Versus Continuous Sacral Neuromodulation for LUTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ICIQ-OAB-QoL score', 'timeFrame': 'Baseline, 12 months post-operatively', 'description': 'ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.'}], 'secondaryOutcomes': [{'measure': 'Change in ICIQ-OAB-QoL score', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.'}, {'measure': 'Change in OAB-q SF', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'OAB-q SF is a 19 question patient-completed survey evaluating symptom bother and quality of life in patients with overactive bladder.'}, {'measure': 'Change in Overactive Bladder Symptom Score (OABSS)', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'The Overactive Bladder Symptom Score (OABSS) is a 4 question validated symptom assessment tool for patients with OAB and assesses number of episodes of frequency, nocturia, urgency, and urge incontinence.'}, {'measure': 'Change in Incontinence Impact Questionnaire SF (IIQ-7)', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': "Incontinence Impact Questionnaire SF (IIQ-7) is a 7-item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale."}, {'measure': 'Urinary Distress Inventory SF (UDI-6)', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': "Urinary Distress Inventory SF (UDI-6) is a 6 item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale."}, {'measure': 'Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'Patient Global Impression of Severity (PGI-S) is a 1-item scale designed to assess for disease severity.'}, {'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'Patient Global Impression of Improvement (PGI-I) is a 1-item scale designed to assess symptom improvement.'}, {'measure': 'Overactive Bladder Satisfaction of Treatment Questionnaire', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': "Change in Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SAT-q) is an 11-item validated questionnaire that assesses patients' satisfaction with their OAB treatment within a clinical setting from baseline."}, {'measure': 'Change in voiding frequency (# of voiding episodes in 24 hours)', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Daily voiding frequency will be the average # of voids per 24h averaged over 3 day bladder diary.'}, {'measure': 'Change in nocturia episodes', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Nocturia episodes will be the average # of voids overnight per day averaged over 3 day bladder diary.'}, {'measure': 'Change in urgency episodes', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Urgency episodes will be the average # of urgency episodes per 24h averaged over 3 day bladder diary.'}, {'measure': 'Change in urinary urge incontinence episodes', 'timeFrame': 'Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively', 'description': 'Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Urinary urge incontinence episodes will be the average # of urinary urge incontinence episodes per 24h averaged over 3 day bladder diary.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Overactive Bladder Syndrome']}, 'descriptionModule': {'briefSummary': 'This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.', 'detailedDescription': '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.\n\nThis will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) in patients undergoing SNM for OAB.\n\nPatients \\> age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM (either stage I lead/temporary 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.\n\nPatients 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 episodes/24h), urinalysis, urine culture (if indicated), post void residuals, and symptom assessments using questionnaires.\n\nOnly 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.\n\nPatients will then be followed with clinical evaluation and questionnaires repeated at 1 month, 6 months, 12 months, 3 years, and 5 years post-op.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Female\n* English Speaking\n* Diagnosis of urinary urge incontinence or overactive bladder\n* 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)\n* Willing and able to complete all study related items\n\nExclusion Criteria:\n\n* Patients less than 18 years of age\n* Unable to provide consent\n* Non-English speaking\n* Relevant neurologic diseases (multiple sclerosis, Parkinson Disease, myasthenia gravis, - - - Charcot-Marie-Tooth disease, complete spinal cord injury)\n* Current or prior bladder malignancy'}, 'identificationModule': {'nctId': 'NCT06170450', 'briefTitle': 'Cyclic Versus Continuous Sacral Neuromodulation for LUTS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'CYclic Versus Continuous Sacral Modulation for LowEr Urinary Tract Symptoms: a Prospective Randomized Controlled Trial (CYCLE Trial)', 'orgStudyIdInfo': {'id': 'STUDY20231521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclic SNM', 'description': 'Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.', 'interventionNames': ['Device: Cyclic SNM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous SNM', 'description': 'Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)', 'interventionNames': ['Device: Continuous SNM']}], 'interventions': [{'name': 'Cyclic SNM', 'type': 'DEVICE', 'description': 'SNM cycling: 8 hours on, 16 hours off', 'armGroupLabels': ['Cyclic SNM']}, {'name': 'Continuous SNM', 'type': 'DEVICE', 'description': "Continuous SNM: on continuously, no 'off' period", 'armGroupLabels': ['Continuous SNM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'David Sheyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available during study recruitment and monitoring. When study has concluded, data will no longer be available.', 'ipdSharing': 'YES', 'description': 'Only de-identified data will be shared with co-collaborators at Northwestern University (PI: Carol E. Bretschneider) and University of Louisville (PI: Ankita Gupta)', 'accessCriteria': 'Available to only (IRB approved) members of study team through secure RedCap'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'University of Louisville', 'class': 'OTHER'}, {'name': 'Metro Health, Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'David Sheyn', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}