Status:
COMPLETED
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
Lead Sponsor:
Mount Sinai Hospital, Canada
Conditions:
Scrotal Pain
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published. We proposed a pilot study using Botox to block the nerves on a small gro...
Eligibility Criteria
Inclusion
- Age 18-65
- Have nociceptive scrotal pain,
- Have no identifiable, reversible causes for the scrotal pain
- Have failed standard medical therapy
- Have responded temporarily to cord blocks
Exclusion
- Are interested in trying to conceive with their partners in the next 6 months,
- Have any local infection near the site of the injections,
- Have had an allergic reaction to Botox in the past,
- Are unable to provide informed consent
- Have a history of motor neuron disease or neurogenic bladder
- Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02249234
Start Date
August 1 2014
End Date
October 1 2018
Last Update
March 11 2019
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5