Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain (ROBOT)
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|ClinicalTrials.gov Identifier: NCT02249234|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : March 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Scrotal Pain||Drug: Botox Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Botox 200 units reconstituted in 10ml of normal saline for a one-time injection
Other Name: OnabotulinumtoxinA
Placebo Comparator: Saline
Saline 10ml of normal saline for a one-time injection
- Reduction in the visual analog scales for pain [ Time Frame: 6 months after entering in trial ]A measure of the change in the visual analog scales for pain.
- Reduction in scrotal pain [ Time Frame: 6 months after entering in trial ]It will be assessed by the Chronic Epididymitis Symptom Index score.
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): NCT02249234
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Keith Jarvi, MD||Mount Sinai Hospital, Canada|