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
|Condition or disease||Intervention/treatment||Phase|
|Scrotal Pain||Drug: Botox||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Botox to Treat Scrotal Pain|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832194
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Keith Jarvi, MD||Mount Sinai Hospital, Canada|