Use of Botox to Treat Scrotal Pain

Scrotal Pain Clinical Trial

Official title:

Use of Botox to Treat Scrotal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832194
• Other study ID #: CAN_BTX
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2013
• Last updated: August 28, 2014
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scrotal Pain

Intervention

Drug:
• Botox

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	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).	6 months after entering in trial	No