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Use of Botox to Treat Scrotal Pain

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status and phase

Completed
Phase 1

Conditions

Scrotal Pain

Treatments

Drug: Botox

Study type

Interventional

Funder types

Other

Identifiers

NCT01832194
CAN_BTX

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Botox
Experimental group
Description:
Botox: A concentrated dose of Onabotulinum Toxin A of 100 units dissolved in 2 cc of 2% xylocaine for a one-time injection.
Treatment:
Drug: Botox

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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