- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02249234
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain (ROBOT)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Botox
Botox 200 units reconstituted in 10ml of normal saline for a one-time injection
|
Other Names:
|
Placebo Comparator: Saline
Saline 10ml of normal saline for a one-time injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after entering in trial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in scrotal pain
Time Frame: 6 months after entering in trial
|
It will be assessed by the Chronic Epididymitis Symptom Index score.
|
6 months after entering in trial
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Jarvi, MD, Mount Sinai Hospital, Canada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAN-BTX-RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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