Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2026-03-06 @ 11:53 AM
Study NCT ID:
NCT01924728
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)', 'timeFrame': 'Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment'}], 'secondaryOutcomes': [{'measure': 'Change in Incontinence Episode Frequency (IEF)', 'timeFrame': 'Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment'}, {'measure': 'Change in 1-hour exercise (stress) pad test', 'timeFrame': 'Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment'}, {'measure': 'Change in Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Week 4, 8. Follow-up at 3-,6- and 12-months post treatment'}, {'measure': 'Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)', 'timeFrame': 'Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '26093910', 'type': 'DERIVED', 'citation': 'Lim R, Liong ML, Leong WS, Khan NA, Yuen KH. Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2015 Jun 21;16:279. doi: 10.1186/s13063-015-0803-1.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female patients with stress urinary incontinence.\n\nBased on the available data on magnetic stimulation, the investigators hypothesize that magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary leakage upon exertion as well as improve patients' quality of life.", 'detailedDescription': 'A total of 120 female patients will be randomly assigned into two treatment groups (active arm and sham arm) in a 1:1 ratio. The standard QRS®-1010 PelviCenter treatment plan involves 16 sessions of 20 minutes each. Each subject will attend 2 sessions per week (total 16 sessions).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged at least 21 years old\n* Demonstration of stress urinary incontinence by vaginal examination with half full bladder (200 to 250ml)\n* ICIQ UI SF score ≥ 6 points\n* Able and agree to carry out one hour pad test\n\nExclusion Criteria:\n\n* Acute severe infections\n* Urinary tract infections and hematuria, active vaginal lesions or infections\n* Pelvic organ prolapse stage III and IV, severe urethral sphincter weakness/defect, suspected fistula\n* Severe cardiac arrhythmia\n* Cardiac pacemaker or other implanted metallic devices\n* History of pelvic irradiation\n* Pregnant, or actively trying to conceive.\n* Neurologic conditions such as epilepsy, Parkinson disease, multiple sclerosis\n* Patient who has been treated with electromagnetic stimulation\n* Concurrent medications with alpha-adrenergic antagonists (e.g. terazosin, tamsulosin, doxazosin), diuretics, serotonin/norepinephrine reuptake inhibitors (SNRIs) or any other medications known to worsen incontinence.\n* Post void residual volume of ≥ 200ml\n* Random blood sugar \\>10 mmol/L\n* Patient who had pelvic or gynaecological surgery for less than three weeks\n* Patient scheduled for pelvic or gynaecological surgery in the next eight weeks'}, 'identificationModule': {'nctId': 'NCT01924728', 'briefTitle': 'Efficacy of Magnetic Stimulation for Stress Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'QRS Asia Sdn Bhd'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Effects of Transpelvic Magnetic Stimulation (Using QRS®-1010 PelviCenter) in Patients With Stress Urinary Incontinence.', 'orgStudyIdInfo': {'id': 'QRSPelvicenter'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnetic stimulation', 'description': 'Active magnetic stimulation delivered to the pelvic floor muscles', 'interventionNames': ['Device: Magnetic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham magnetic stimulation', 'description': 'Sham magnetic stimulation delivered to the pelvic floor muscles', 'interventionNames': ['Device: Sham magnetic stimulation']}], 'interventions': [{'name': 'Magnetic stimulation', 'type': 'DEVICE', 'description': '50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles', 'armGroupLabels': ['Magnetic stimulation']}, {'name': 'Sham magnetic stimulation', 'type': 'DEVICE', 'description': '50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles', 'armGroupLabels': ['Sham magnetic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10450', 'city': 'George Town', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Island Hospital', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}], 'overallOfficials': [{'name': 'Liong Men Long, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Island Hospital, Penang'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QRS Asia Sdn Bhd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, {'name': 'Island Hospital', 'class': 'OTHER'}, {'name': 'Penang Adventist Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M. Pharm', 'investigatorFullName': 'Lim Renly', 'investigatorAffiliation': 'QRS Asia Sdn Bhd'}}}}