CompletedPhase 1

Use of Botox to Treat Scrotal Pain

Canada20 participantsStarted 2013-03

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Change in pain

Timeframe: 6 months after entering in trial

Trial details

NCT IDNCT01832194

SponsorMount Sinai Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Scrotal Pain trials