Use of Botox to Treat Scrotal Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01832194
First received: April 11, 2013
Last updated: August 28, 2014
Last verified: April 2013
  Purpose

There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal pain that we found published. We propose a pilot study to use Botox to block the testicular nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using marcaine. Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men would be asked to fill in visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.


Condition Intervention Phase
Scrotal Pain
Drug: Botox
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Botox to Treat Scrotal Pain

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Change in pain [ Time Frame: 6 months after entering in trial ] [ Designated as safety issue: No ]
    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).


Enrollment: 20
Study Start Date: March 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox

Botox:

A concentrated dose of Onabotulinum Toxin A of 100 units dissolved in 2 cc of 2% xylocaine for a one-time injection.

Drug: Botox
Other Name: Onabotulinum Toxin A

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01832194

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

No publications provided

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01832194     History of Changes
Other Study ID Numbers: CAN_BTX
Study First Received: April 11, 2013
Last Updated: August 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Scrotal pain
Botox

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014