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

Phase 2

Completed

• Conditions: Scrotal Pain
• Interventions: Drug: Placebo; Drug: Botox

• Registration Number: NCT02249234
• Lead Sponsor: Mount Sinai Hospital, Canada

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Saline 10ml of normal saline for a one-time injection
Botox	Botox	Botox 200 units reconstituted in 10ml of normal saline for a one-time injection

Primary Outcome Measures

Name	Time	Method
Reduction in the visual analog scales for pain	6 months after entering in trial	A measure of the change in the visual analog scales for pain.

Secondary Outcome Measures

Name	Time	Method
Reduction in scrotal pain	6 months after entering in trial	It will be assessed by the Chronic Epididymitis Symptom Index score.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada