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Use of Botox to Treat Scrotal Pain

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.
 
ClinicalTrials.gov Identifier: NCT01832194
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Tracking Information
First Submitted Date  ICMJE April 11, 2013
First Posted Date  ICMJE April 15, 2013
Last Update Posted Date September 1, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Botox to Treat Scrotal Pain
Official Title  ICMJE Use of Botox to Treat Scrotal Pain
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Scrotal Pain
Intervention  ICMJE Drug: Botox
Other Name: Onabotulinum Toxin A
Study Arms  ICMJE 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.

Intervention: Drug: Botox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01832194
Other Study ID Numbers  ICMJE CAN_BTX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mount Sinai Hospital, Canada
Study Sponsor  ICMJE Mount Sinai Hospital, Canada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Jarvi, MD Mount Sinai Hospital, Canada
PRS Account Mount Sinai Hospital, Canada
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP