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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
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Botox
Botox 200 units reconstituted in 10ml of normal saline for a one-time injection
Drug: Botox
Other Name: OnabotulinumtoxinA

Placebo Comparator: Saline
Saline 10ml of normal saline for a one-time injection
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reduction in scrotal pain [ Time Frame: 6 months after entering in trial ]
    It will be assessed by the Chronic Epididymitis Symptom Index score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Keith Jarvi, MD Mount Sinai Hospital, Canada

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02249234     History of Changes
Other Study ID Numbers: CAN-BTX-RCT
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Keywords provided by Mount Sinai Hospital, Canada:
Scrotal pain
Botox
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents