A Randomized, Double-Blind, Controlled Trial Shows that Onabotulinum Toxin A Nerve Blocks do Not Provide Improved Pain Control in Men with Chronic Scrotal Pain.

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  • Additional Information
    • Source:
      Publisher: Wolters Kluwer Country of Publication: United States NLM ID: 0376374 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-3792 (Electronic) Linking ISSN: 00225347 NLM ISO Abbreviation: J Urol Subsets: MEDLINE
    • Publication Information:
      Publication: 2019- : [Philadelphia, PA] : Wolters Kluwer
      Original Publication: Baltimore : Lippincott Williams & Wilkins
    • Subject Terms:
      Botulinum Toxins, Type A/*administration & dosage ; Chronic Pain/*therapy ; Nerve Block/*methods ; Neurotoxins/*administration & dosage ; Pain Management/*methods ; Testicular Diseases/*therapy; Adult ; Chronic Pain/diagnosis ; Double-Blind Method ; Humans ; Male ; Middle Aged ; Pain Measurement ; Quality of Life ; Testicular Diseases/diagnosis ; Testis/innervation ; Treatment Outcome
    • Abstract:
      Purpose: The use of onabotulinum toxin A to chemically denervate the testis has been studied as a minimally invasive therapy to treat chronic scrotal pain. To our knowledge no randomized, controlled trials of onabotulinum toxin A for chronic scrotal pain management have been reported to date.
      Materials and Methods: In this double-blind, randomized, controlled trial men with chronic scrotal pain who achieved at least temporary pain relief following a cord block with local anesthesia were randomly assigned to a block using local anesthesia alone vs local anesthesia plus 200 IU onabotulinum toxin A. Standardized assessments of pain levels using a visual analogue score, disease impact, quality of life and mood were performed 1, 2, 3, 4, 12 and 18 weeks after injection. The study primary outcome was the change in the visual analogue score at 1 month. After study completion the men in the control group were given the option to receive onabotulinum toxin A as part of an open label trial.
      Results: Of 64 men with a mean ± SD age of 45.9 ± 11 years and a mean 5.7 ± 5.7-year history of pain 32 received local anesthesia plus onabotulinum toxin A and 32 received local anesthesia alone. There was no statistically significant difference in any measured outcome when comparing those who received onabotulinum toxin A to controls. Nine of the 13 men (69.2%) in the open label trial achieved an improvement in the visual analogue score (mean group score 6.1 ± 1.66 to 4.5 ± 2.36, Student t-test p=0.022) with a reduction in persistent pain at 3 months in 6 of the 9 (66.7%).
      Conclusions: This randomized, double-blind, controlled trial showed no superiority of onabotulinum toxin A plus local anesthesia over local anesthesia alone for pain control in men with chronic scrotal pain. Interestingly, significant pain improvement was noted in our open label onabotulinum toxin A trial, suggesting a potential placebo effect.
    • Comments:
      Comment in: J Urol. 2020 Apr;203(4):772. (PMID: 31916924)
      Comment in: J Urol. 2020 Apr;203(4):772. (PMID: 31916925)
    • Contributed Indexing:
      Keywords: botulinum toxins; nerve block; pelvic pain; scrotum; testis; type A
    • Accession Number:
      0 (Neurotoxins)
      EC 3.4.24.69 (Botulinum Toxins, Type A)
      EC 3.4.24.69 (onabotulinum toxin A)
    • Publication Date:
      Date Created: 20191119 Date Completed: 20200420 Latest Revision: 20200420
    • Publication Date:
      20240829
    • Accession Number:
      10.1097/JU.0000000000000658
    • Accession Number:
      31738115