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

Mount Sinai Hospital, Canada64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Scrotal Pain

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reduction in the visual analog scales for pain

A measure of the change in the visual analog scales for pain.

Time frame: 6 months after entering in trial

Secondary Outcomes

Reduction in scrotal pain

It will be assessed by the Chronic Epididymitis Symptom Index score.