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Use of Botox to Treat Scrotal Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832194
First Posted: April 15, 2013
Last Update Posted: September 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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): 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

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01832194     History of Changes
Other Study ID Numbers: CAN_BTX
First Submitted: April 11, 2013
First Posted: April 15, 2013
Last Update Posted: September 1, 2014
Last Verified: April 2013

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

Additional relevant MeSH terms:
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents