Use of Botox to Treat Scrotal Pain

• ClinicalTrials.gov Identifier: NCT01832194
• Recruitment Status: Completed
• First Posted: April 15, 2013
• Last Update Posted: September 1, 2014
• Sponsor: Mount Sinai Hospital, Canada
• Information provided by (Responsible Party): Mount Sinai Hospital, Canada

Tracking Information

• First Submitted Date: April 11, 2013
• First Posted Date: April 15, 2013
• Last Update Posted Date: September 1, 2014
• Study Start Date: March 2013
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2013)

Change in pain [ Time Frame: 6 months after entering in trial ]

Change in pain is measured by visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI) before therapy and 1, 3 and 6 months post therapy. In addition, physical examination of the testis and epididymis and sensory testing of the skin of the scrotum and anterior thigh before the therapy and 1, 3 and 6 months post therapy. The sensory testing will be the patients' subjective reporting of the sensation felt with light touch (normal, decreased, increased or painful) and pin prick (decreased, normal or increased) in the skin of the scrotum and anterior thigh of the treated side (the side where the therapy was used) compared to the untreated side (where no therapy was used).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Botox to Treat Scrotal Pain
• Official Title: Use of Botox to Treat Scrotal Pain
• Brief Summary: There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal pain that we found published. We propose a pilot study to use Botox to block the testicular nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using marcaine. Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men would be asked to fill in visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Scrotal Pain

Intervention

Drug: Botox

Other Name: Onabotulinum Toxin A

Study Arms

Experimental: Botox

Botox:

A concentrated dose of Onabotulinum Toxin A of 100 units dissolved in 2 cc of 2% xylocaine for a one-time injection.

Intervention: Drug: Botox

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 11, 2013): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01832194
• Other Study ID Numbers: CAN_BTX
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mount Sinai Hospital, Canada
• Study Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Not Provided

Investigators

• Principal Investigator: Keith Jarvi, MD; Mount Sinai Hospital, Canada

• PRS Account: Mount Sinai Hospital, Canada
• Verification Date: April 2013