Use of Botox to Treat Scrotal Pain
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Botox to Treat Scrotal Pain|
- Change in pain [ Time Frame: 6 months after entering in trial ] [ Designated as safety issue: No ]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).
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
A concentrated dose of Onabotulinum Toxin A of 100 units dissolved in 2 cc of 2% xylocaine for a one-time injection.
Other Name: Onabotulinum Toxin A
Please refer to this study by its ClinicalTrials.gov identifier: NCT01832194
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Keith Jarvi, MD||Mount Sinai Hospital, Canada|