CompletedPhase 2

Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

Canada64 participantsStarted 2014-08

Plain-language 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 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. The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo. We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.

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

Reduction in the visual analog scales for pain

Timeframe: 6 months after entering in trial

Trial details

NCT IDNCT02249234

SponsorMount Sinai Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10

View on ClinicalTrials.gov More Scrotal Pain trials