Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02328092
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-12', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-26', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of bedwetting/week', 'timeFrame': '2.5 months', 'description': 'Measurment of number of bedwetting/week one month before session, session, after first and second week of stimulation and one month later'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '1.5 month', 'description': 'Assessment of Quality of life'}, {'measure': 'VAS', 'timeFrame': '1.5 month', 'description': 'Measurment of VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nocturnal Enuresis']}, 'referencesModule': {'references': [{'pmid': '26409403', 'type': 'DERIVED', 'citation': 'Khedr EM, Elbeh KA, Abdel Baky A, Abo-Elfetoh N, El-Hammady DH, Korashy F. A double-blind randomized clinical trial on the efficacy of magnetic sacral root stimulation for the treatment of Monosymptomatic Nocturnal Enuresis. Restor Neurol Neurosci. 2015;33(4):435-45. doi: 10.3233/RNN-150507.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.', 'detailedDescription': 'The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis. Eligible patients were randomized to receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical excitability of upper and lower limbs were done before and after the end of sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects diagnosed as patients with primary monosymptomatic nocturnal enuresis according to the Diagnostic and statistical manual of mental disorders, 4th revised edn (DSM-IV)\n\nExclusion Criteria:\n\n* We exclude any patient with pacemakers or any metallic devices\n* Patients with evidence of urinary tract infection.'}, 'identificationModule': {'nctId': 'NCT02328092', 'briefTitle': 'A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Therapeutic Effect of Sacral Root Stimulation on Nocturnal Enuresis', 'orgStudyIdInfo': {'id': 'rSMS in nocturnal enuresis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Real group', 'description': 'The real group received biphasic rSMS using a Magstim Super Rapid (Magstim, Whitland, UK) stimulator connected to a 120-mm outer diameter figure-of-8 air film cooling coil positioned in the midline over the sacral vertebrae (approximately 5 cm above the natal cleft, which approximates to the level of S2). Stimulation was delivered at 15 Hz at 50% of maximum stimulator output (10 seconds on and 30 seconds off) with a total of 1500 pulses and the hand of the coil upward. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off.', 'interventionNames': ['Device: rSMS in treatment of Nocturnal Enuresis']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'The control group received sham rSMS stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.', 'interventionNames': ['Device: rSMS in treatment of Nocturnal Enuresis']}], 'interventions': [{'name': 'rSMS in treatment of Nocturnal Enuresis', 'type': 'DEVICE', 'description': 'Real rSMS (15 Hz at 50% of maximum stimulator output (10 seconds on and 30 seconds off) with a total of 1500 pulses and the hand of the coil upword. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off. Sham rSMS received stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.', 'armGroupLabels': ['Real group', 'Sham Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Eman M. Khedr', 'investigatorAffiliation': 'Assiut University'}}}}