Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01477502
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2011-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006705', 'term': 'Homeopathy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of symptomatic urinary tract infections', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'number of symptomatic urinary tract infections compared to the previous year', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary tract infection', 'spinal cord injury', 'homeopathy', 'prevention'], 'conditions': ['Symptomatic Urinary Tract Infection', 'Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '29485355', 'type': 'DERIVED', 'citation': 'Pannek J, Pannek-Rademacher S, Jus MS, Wollner J, Krebs J. Usefulness of classical homeopathy for the prophylaxis of recurrent urinary tract infections in individuals with chronic neurogenic lower urinary tract dysfunction. J Spinal Cord Med. 2019 Jul;42(4):453-459. doi: 10.1080/10790268.2018.1440692. Epub 2018 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life.\n\n* until today, there is no effective prophylaxis for UTI for patients with spinal cord injury.\n* homeopathy has been shown to be an effective treatment option in several chronic diseases\n* study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neurogenic bladder dysfunction treated by intermittent catheterization\n* recurrent (\\>3/year) symptomatic urinary tract infections\n\nExclusion Criteria:\n\n* inability to speak German\n* already under homeopathic treatment'}, 'identificationModule': {'nctId': 'NCT01477502', 'briefTitle': 'Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2011-24'}, 'secondaryIdInfos': [{'id': '11050', 'type': 'OTHER', 'domain': 'Ethical committe of the Kanton Lucerne, Switzerland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'individual homeopathic treatment', 'description': 'participants receive homeopathic treatment in addition to standard prevention measures for UTI', 'interventionNames': ['Other: individual homeopathic treatment']}, {'type': 'OTHER', 'label': 'standard prophylaxis', 'interventionNames': ['Other: standard treatment without homeopathy']}], 'interventions': [{'name': 'individual homeopathic treatment', 'type': 'OTHER', 'description': 'participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis', 'armGroupLabels': ['individual homeopathic treatment']}, {'name': 'standard treatment without homeopathy', 'type': 'OTHER', 'description': 'participants receive standard UTI prophylaxis', 'armGroupLabels': ['standard prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic center', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Jürgen Pannek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}