Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 12:22 AM
Study NCT ID:
NCT02249234
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2014-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the visual analog scales for pain', 'timeFrame': '6 months after entering in trial', 'description': 'A measure of the change in the visual analog scales for pain.'}], 'secondaryOutcomes': [{'measure': 'Reduction in scrotal pain', 'timeFrame': '6 months after entering in trial', 'description': 'It will be assessed by the Chronic Epididymitis Symptom Index score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scrotal pain', 'Botox'], 'conditions': ['Scrotal Pain']}, 'descriptionModule': {'briefSummary': 'There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.\n\nWe proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.\n\nThe encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.\n\nWe hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.'}, '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': 'NCT02249234', 'acronym': 'ROBOT', 'briefTitle': 'Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain', 'orgStudyIdInfo': {'id': 'CAN-BTX-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botox', 'description': 'Botox 200 units reconstituted in 10ml of normal saline for a one-time injection', 'interventionNames': ['Drug: Botox']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline 10ml of normal saline for a one-time injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'otherNames': ['OnabotulinumtoxinA'], 'armGroupLabels': ['Botox']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Saline']}]}, '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'}}}}