Botulinum Toxin A as a Treatment for Provoked Vestibulodynia A Randomized Controlled TrialShow others and affiliations
2020 (English)In: Obstetrics and Gynecology, ISSN 0029-7844, E-ISSN 1873-233X, Vol. 136, no 3, p. 524-532Article in journal (Refereed) Published
Abstract [en]
OBJECTIVE: To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia. METHODS: We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76 +/- 31 SD). RESULTS: Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported. CONCLUSION: Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment.
Place, publisher, year, edition, pages
LIPPINCOTT WILLIAMS & WILKINS , 2020. Vol. 136, no 3, p. 524-532
National Category
Physiotherapy Gynaecology, Obstetrics and Reproductive Medicine Health Sciences
Identifiers
URN: urn:nbn:se:mdh:diva-51322DOI: 10.1097/AOG.0000000000004008ISI: 000571162000012PubMedID: 32769643Scopus ID: 2-s2.0-85089810503OAI: oai:DiVA.org:mdh-51322DiVA, id: diva2:1474379
2020-10-082020-10-082025-02-11Bibliographically approved