Methodological approaches to botulinum toxin for the treatment of chronic pelvic pain, vaginismus, and vulvar pain disorders
Introduction and hypothesis
Botulinum toxin (BoNT) is increasingly used for pain, especially with muscle spasm. We describe our methodology for BoNT treatment of chronic pelvic pain (CPP) in women and place it in the context of the literature on techniques for this use.
Databases were searched using terms “botulinum toxin,” “pelvic pain,” and “vaginismus.” Reports on vaginismus/vulvodynia/vestibulodynia (included if pelvic floor muscles were injected) were grouped as “vaginismus/vulvar pain disorders” (V/VPD). We analyzed the type of report, condition, toxin serotype/brand, dose/dilution, muscle selection, guidance technique, and anesthesia. Publications from the same authors without unique information were combined for specific analyses.
Thirty-eight reports had analyzable information; many lacked complete information. Most were open-label prospective reports; there were four technical reports, one randomized comparison of doses and one placebo-controlled study of efficacy. Pelvic floor muscles were approached transvaginally, transperineally or transgluteally. BoNT brand/dose/dilution varied widely. Muscle localization techniques included anatomical landmarks only, electromyography, electrical stimulation with/without ultrasound, and fluoroscopy/CT scanning. Papers discussing analgesia utilized general anesthesia, conscious sedation with/without topical/local anesthesia, topical/local agent alone or pudendal block before or after injection. Cumulatively, 58–100% of patients with CPP and 71–100% of those with V/VPD improved. Serious adverse events (transient fecal incontinence/constipation, urinary incontinence/retention) were more frequent with higher doses.
BoNT can be safely and tolerably injected into pelvic floor muscles in women as an out-patient procedure. This study identifies methodological factors to be considered in future studies and the critical need for high-quality clinical trials for this emerging treatment.
KeywordsBotulinum toxin Chemodenervation Chronic pelvic pain Pelvic floor spasm Pelvic pain Vaginismus
Source of funding
This research was supported by the Intramural Research Program of the National Institutes of Health.
Compliance with ethical standards
Conflicts of interest
The authors declare that they have no conflicts of interest related to this article.
Dr Karp, Dr Stratton are investigators and Ms Tandon was a research assistant on a different study for which the National Institutes of Health received a grant from Allergan, Inc, the manufacturer of onabotulinumtoxinA (Botox). Dr Karp is also an associate investigator on one study for which the Icahn School of Medicine at Mt Sinai received a grant from Allergan, Inc, and another study for which the National Institutes of Health received a grant from Merz, Inc, the manufacturer of incobotulinumtoxinA (Xeomin). Ms Vigil has no disclosures.
- 18.Matak I, Lackovic Z. Botulinum toxin A, brain and pain. Prog Neurobiol. 2014;119-120:39–59.Google Scholar
- 23.Stratton P, Tandon H, Sinaii N, Shah J, Karp BI. Botulinum toxin for chronic pelvic pain in endometriosis. World Congress on Endometriosis. Vancouver, B.C. 2017.Google Scholar
- 29.Bhide A, Bray R, Gopalan V, Fernando R, Khullar V, Digesu A. To assess whether botulinum type A toxin injection to the pelvic floor improves symptoms and quality of life in women with chronic pelvic pain (CPP) due to pelvic floor muscle hyperalgesia. Neurourol Urodyn. 2014;33:1025.Google Scholar
- 33.El-Khawand D, Wehbe S, O'Hare P, et al. Botulinum toxin a injections into pelvic floor muscles under electromyographic guidance for women with refractory high tone pelvic floor dysfunction: three-month follow-up data of an ongoing pilot study. Neurourol Urodyn. 2013;32:117.Google Scholar
- 34.Morrissey D, El-Khawand D, Ginzburg N, Wehbe S, O'Hare P III, Whitmore K. Botulinum toxin A injections into pelvic floor muscles under electromyographic guidance for women with refractory high-tone pelvic floor dysfunction: a 6-month prospective pilot study. Female Pelvic Med Reconstr Surg. 2015;21:277–82.CrossRefGoogle Scholar
- 39.Ghazizadeh S, Abedi J, Pourmatroud AJ, Raiisi F, Lesanpezeshki M. Comparison of 500 units vs 250 units of botulinum toxin (abobotulinumtoxinA) for the treatment of severe vaginismus. J Bacteriol Mycol. 2016;3:1033–6.Google Scholar
- 41.Greenleaf BA, McKinney TB, Greenleaf BA, et al. Vaginismus and botulinum toxin a: A measurement of treatment. Female Pelvic Med Reconstr Surg. 2011;17:S93.Google Scholar
- 42.Halder GE, Scott L, Wyman AM, Mora N, Bassaly R, Hoyte L. Botox with physical therapy for myofascial pelvic pain. Female Pelvic Med Reconstr Surg. 2015;21:S143.Google Scholar
- 46.Moreland A, Minwell G, Kieger A, Yim D, Hong K. CT-guided intramuscular injection of botulinum toxin A for treatment of myofascial pelvic pain: single center evaluation of safety and early efficacy (abstract). Radiol Soc N Amer 2016 Scientific Assembly and Annual Meeting, November 27–December 2, 2016, Chicago IL. 2016. archive.rsna.org/2016/16003493.html. Accessed 27 February 2017.
- 48.Orasanu B, Guetzko ME, Mahajan S. Myobloc® for the treatment of myofascial pelvic pain secondary resistant to Botox®. Female Pelvic Med Reconstr Surg. 2013;19:S114.Google Scholar
- 54.Quirino W, James RL, Mahajan ST. Pelvic floor botulinum a toxin injection for the treatment of myofascial pelvic pain. J Pelvic Med Surg. 2010;16:S164.Google Scholar
- 57.Pacik P. Vaginismus: treatment using the botulinum toxin A program. J Sexual Med. 2013;10:177.Google Scholar
- 58.Pacik P. Vaginismus: treatment with intravaginal Botox and dilation under anesthesia. A prospective study of 70 consecutive patients. J Sex Med. 2011;8:64.Google Scholar