Botulinum toxin type A for the treatment of provoked vestibulodynia: An open-label, pilot study

OBJECTIVE: To evaluate the effects of botulinum toxin type A for the treatment of provoked vestibulodynia. STUDY DESIGN: Open-label, dose-escalation, pilot study. Primary outcome measure was a standard numeric pain rating scale of 0-10. Secondary measures were improvements in quality of life and change in medication use. RESULTS: The 7 patients who received 35 units of botulinum toxin type A had a baseline mean pain score (0-10) of 8.1 (SD = 0.70). Thirty days after treatment, these patients had a mean pain score of 2.9 (SD = 1.17). The duration of effect was 8 weeks, and there were no side effects. The 12 patients who received 50 units of botulinum toxin type A had a baseline mean pain score of 7.4 (SD = 0.10). Thirty days after treatment, these patients had a mean pain score of 1.8 (SD = 0.72). The duration of effect was 14 weeks, and there were no side effects. Significant improvement was also seen in medication use and quality of life for these patients. CONCLUSION: This study provides further clinical evidence of the nociceptive effects of botulinum toxin type A in pelvic inflammatory pain-related disorders. Doubleblind, placebo-controlled trials to evaluate the efficacy of botulinum toxin in treating patients with provoked vestibulodynia are warranted.