Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT01832194
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2013-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Botox to Treat Scrotal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C000629279', 'term': 'onabotulinum toxin A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': '6 months after entering in trial', 'description': "Change in pain is measured by visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI) before therapy and 1, 3 and 6 months post therapy. In addition, physical examination of the testis and epididymis and sensory testing of the skin of the scrotum and anterior thigh before the therapy and 1, 3 and 6 months post therapy. The sensory testing will be the patients' subjective reporting of the sensation felt with light touch (normal, decreased, increased or painful) and pin prick (decreased, normal or increased) in the skin of the scrotum and anterior thigh of the treated side (the side where the therapy was used) compared to the untreated side (where no therapy was used)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scrotal pain', 'Botox'], 'conditions': ['Scrotal Pain']}, 'descriptionModule': {'briefSummary': 'There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal pain that we found published. We propose a pilot study to use Botox to block the testicular nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using marcaine. Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men would be asked to fill in visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65\n* Have nociceptive scrotal pain,\n* Have no identifiable, reversible causes for the scrotal pain\n* Have failed standard medical therapy\n* Have responded temporarily to cord blocks\n\nExclusion Criteria:\n\n* Are interested in trying to conceive with their partners in the next 6 months,\n* Have any local infection near the site of the injections,\n* Have had an allergic reaction to Botox in the past,\n* Are unable to provide informed consent\n* Have a history of motor neuron disease or neurogenic bladder\n* Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners'}, 'identificationModule': {'nctId': 'NCT01832194', 'briefTitle': 'Use of Botox to Treat Scrotal Pain', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Use of Botox to Treat Scrotal Pain', 'orgStudyIdInfo': {'id': 'CAN_BTX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botox', 'description': 'Botox:\n\nA concentrated dose of Onabotulinum Toxin A of 100 units dissolved in 2 cc of 2% xylocaine for a one-time injection.', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'otherNames': ['Onabotulinum Toxin A'], 'armGroupLabels': ['Botox']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Keith Jarvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}