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

NCT02249234 | Completed Phase 2

• 1 other identifier: CAN-BTX-RCT
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Scrotal Pain

Keywords

Scrotal pain; Botox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in scrotal pain

  6 months after entering in trial

Study Arms (2)

Botox

EXPERIMENTAL

Botox 200 units reconstituted in 10ml of normal saline for a one-time injection

Drug: Botox

Saline

PLACEBO COMPARATOR

Saline 10ml of normal saline for a one-time injection

Drug: Placebo

Interventions

Botox DRUG

Also known as: OnabotulinumtoxinA

Botox

Placebo DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Keith Jarvi, MD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 25, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

CA (1)