Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT00688506
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2008-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-02', 'studyFirstSubmitDate': '2008-05-29', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)', 'timeFrame': 'before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment'}], 'secondaryOutcomes': [{'measure': 'Brain activity assessed by functional MRI', 'timeFrame': 'before treatment, after 12 weeks of treatment'}, {'measure': 'Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database', 'timeFrame': 'before treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pelvic pain syndrome', 'Neuromodulation', 'Brain effects', 'Neuroimaging'], 'conditions': ['Chronic Pelvic Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '25546177', 'type': 'DERIVED', 'citation': 'Kessler TM, Mordasini L, Weisstanner C, Juni P, da Costa BR, Wiest R, Thalmann GN. Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial. PLoS One. 2014 Dec 29;9(12):e113368. doi: 10.1371/journal.pone.0113368. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.\n\nWe hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CPSS III\n* symptomatic \\>3 months\n* NIH-CPSI total score =/\\>15\n* NIH-CPSI pain =/\\>8\n\nExclusion Criteria:\n\n* post void residual \\>100mL\n* urinary tract infection\n* urethral stricture\n* prostate cancer\n* age \\<18 years\n* claustrophobia\n* pacemaker, neurostimulator, insulin / pain pump'}, 'identificationModule': {'nctId': 'NCT00688506', 'briefTitle': 'Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'KEK 292/07'}, 'secondaryIdInfos': [{'id': '1492'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Combined sono-electro-magnetic therapy', 'interventionNames': ['Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo therapy', 'interventionNames': ['Device: placebo therapy (Placebo Sonodyn Medico Star)']}], 'interventions': [{'name': 'combined sono-electro-magnetic therapy (Sonodyn Medico Star)', 'type': 'DEVICE', 'otherNames': ['Sonodyn Medico Star'], 'description': 'twice a day for 10 minutes during 12 weeks', 'armGroupLabels': ['1']}, {'name': 'placebo therapy (Placebo Sonodyn Medico Star)', 'type': 'DEVICE', 'otherNames': ['Placebo Sonodyn Medico Star device'], 'description': 'twice a day for 10 minutes during 12 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Urology, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Thomas M Kessler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, University of Bern, 3010 Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thomas M. Kessler, MD', 'oldOrganization': 'Department of Urology, University of Bern, 3010 Bern'}}}}