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Methodological approaches to botulinum toxin for the treatment of chronic pelvic pain, vaginismus, and vulvar pain disorders

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Abstract

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.

Methods

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.

Results

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.

Conclusions

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.

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Funding

This research was supported by the Intramural Research Program of the National Institutes of Health.

Author information

Author notes

  1. Barbara Illowsky Karp

    Present address: National Institute of Neurological Disorders and Stroke, National Institutes of Health, Building 31; Room B2 B32, 9000 Rockville Pike, Bethesda, MD, USA

  2. Hannah Tandon

    Present address: , PO Box 425, Carmel, CA, 93921, USA

Authors and Affiliations

  1. National Institute of Neurological Disorders and Stroke, National Institutes of Health, Building 31; Room B2 B32, 9000 Rockville Pike, Bethesda, MD, USA

    Deionna Vigil & Pamela Stratton

  2. Department of Rehabilitation Medicine, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA

    Hannah Tandon

Authors
  1. Barbara Illowsky Karp
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  2. Hannah Tandon
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Corresponding author

Correspondence to Barbara Illowsky Karp.

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The authors declare that they have no conflicts of interest related to this article.

Disclosures

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.

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Karp, B.I., Tandon, H., Vigil, D. et al. Methodological approaches to botulinum toxin for the treatment of chronic pelvic pain, vaginismus, and vulvar pain disorders. Int Urogynecol J 30, 1071–1081 (2019). https://doi.org/10.1007/s00192-018-3831-z

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