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

Scrotal Pain Clinical Trial

— ROBOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249234
• Other study ID #: CAN-BTX-RCT
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Scrotal Pain

Intervention

Drug:
• Botox

• Placebo

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the visual analog scales for pain	A measure of the change in the visual analog scales for pain.	6 months after entering in trial
Secondary	Reduction in scrotal pain	It will be assessed by the Chronic Epididymitis Symptom Index score.	6 months after entering in trial