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Completed

NCT Number: NCT02249234

Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

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.

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Key information

Conditions

Scrotal Pain

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox

Drug

Other names: OnabotulinumtoxinA

Placebo

Drug

Primary outcomes

  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 outcomes

  1. Reduction in scrotal pain

    Time frame: 6 months after entering in trial

    It will be assessed by the Chronic Epididymitis Symptom Index score.

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Acronym: ROBOT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2014
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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