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Injectable Botulinum Toxin for Pelvic Pain: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Last updated: August 22, 2019
Project Number: RC1170-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of injectable botulinum toxin for pelvic floor pain?
  2. What is the cost-effectiveness of injectable botulinum toxin for pelvic floor pain?
  3. What are the evidence-based guidelines regarding injectable botulinum toxin for pelvic floor pain?

Key Message

Two systematic reviews and three randomized controlled trials provided evidence on the clinical effectiveness of injectable botulinum toxin for pelvic floor pain. Two systematic reviews were identified regarding the clinical effectiveness of botulinum toxin type A injections for pelvic floor pain (female sexual pain and vaginismus). Botulinum toxin type A injections appeared to have no effect on pain, sexual functioning, or quality of life when compared to placebo. One systematic review included one study examining botulinum toxin compared with placebo; 100% of patients (n = 8) treated with botulinum toxin injection achieved successful intercourse compared with 0% (n = 5) of patients treated with placebo.Evidence from two randomized controlled trials comparing botulinum toxin A injections with placebo for patients with myofascial pelvic pain or provoked vestibulodynia showed no difference between groups in pain reduction. One RCT provided physiotherapy for both placebo and intervention groups after four weeks in patients with myofascial pelvic pain; there were no differences in pain or sexual functioning between the groups who received botulinum injection and physiotherapy and placebo and physiotherapy. A third randomized controlled trial reported that physiotherapy was more effective than injections of botulinum toxin type A in patients with vaginismus for female sexual functioning index components and success of sexual intercourse.No evidence regarding the cost-effectiveness of botulinum toxin, and no guidelines or recommendations regarding injectable botulinum toxin for pelvic floor pain, were identified.