Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-02 @ 6:36 AM
Study NCT ID:
NCT01074567
Status:
UNKNOWN
Last Update Posted:
2011-04-05
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DMSO Efficacy in IC/PBS Patients During and After Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'D004121', 'term': 'Dimethyl Sulfoxide'}], 'ancestors': [{'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-04', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "O'leary-Sant interstitial cystitis symptom and problem questionaire", 'timeFrame': 'before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment'}], 'secondaryOutcomes': [{'measure': 'urination diary', 'timeFrame': 'before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystitis, Interstitial']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.painful-bladder.org/index.html', 'label': 'international painful bladder foundation'}, {'url': 'http://www.ichelp.org', 'label': 'interstitial cystitis association'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).', 'detailedDescription': "The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. Amitryptiline) and intra-vesical instillation (e.g. DMSO, steroids, heparin). These treatments were found to be effective in a number of studies and are approved by the FDA. However, the optimal duration of intra-vesical instilation is not known.\n\nAll patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO. All patients will fill an O'leary-Sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with IC according to International Continence Society:\n\n * more than 6 month of pelvic pain\n * urinary frequency, urgency, dyspareunia\n\nExclusion Criteria:\n\n* genitourinary tract infection\n* known genitourinary malformation'}, 'identificationModule': {'nctId': 'NCT01074567', 'briefTitle': 'DMSO Efficacy in IC/PBS Patients During and After Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Efficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After Treatment', 'orgStudyIdInfo': {'id': '174/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DMSO cocktail', 'description': 'intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%', 'interventionNames': ['Drug: DMSO cocktail']}], 'interventions': [{'name': 'DMSO cocktail', 'type': 'DRUG', 'otherNames': ['Dimethyl sulfoxide'], 'description': 'intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%', 'armGroupLabels': ['DMSO cocktail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Zeriffin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Kobi Stav, MD', 'role': 'CONTACT', 'email': 'stavkobi@yahoo.com.au', 'phone': '+972-577346778'}, {'name': 'Miki Haifler, MD', 'role': 'CONTACT', 'email': 'mikihaifler@gmail.com', 'phone': '+972-523271255'}], 'facility': 'Assaf Harofe Medical Center'}], 'centralContacts': [{'name': 'Kobi Stav, MD', 'role': 'CONTACT', 'email': 'stavkobi@gmail.com', 'phone': '+972-8-9779400'}, {'name': 'Miki Haifler, MD', 'role': 'CONTACT', 'email': 'mikihaifler@gmail.com', 'phone': '+972-8-9401'}], 'overallOfficials': [{'name': 'Kobi Stav, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assaf-Harofe MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Miki Haifler', 'oldOrganization': 'Assaf-Harofeh Medical Center'}}}}