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

Mount Sinai Hospital, Canada

Status and phase

Completed

Phase 2

Conditions

Scrotal Pain

Treatments

Drug: Placebo

Drug: Botox

Study type

Interventional

Funder types

Other

Identifiers

NCT02249234

CAN-BTX-RCT

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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