• Amélie Levesque, Stéphane Ploteau, Fabrice Michel, Laurent Siproudhis, Eric Bautrant, Julie Eggermont, Benoit Rabischong, Christelle Volteau, Marie-Aimée Perrouin-Verbe, and Jean-Jacques Labat.
• Urology Department, Federative Pelvic Pain Center, Nantes University Hospital, 44093 Nantes, France. Electronic address: amelie.levesque@chu-nantes.fr.
• Ann Phys Rehabil Med. 2021 Jan 1; 64 (1): 101354.

BackgroundMany studies have demonstrated a link between pelvic floor myofascial syndromes and chronic pelvic pain. Botulinum toxin has been extensively used for several years in the field of pain, especially due to its action on muscle spasm. However, the efficacy of botulinum toxin in the context of chronic pelvic pain remains controversial.ObjectivesThis multicentre, randomized, controlled, double-blind study was designed to compare the efficacy of botulinum toxin and local anaesthetic (LA) injection versus LA injection alone for pelvic floor myofascial syndrome and chronic pelvic pain.MethodsAccording to the number of painful trigger points detected on physical examination, patients received from 1 to 4 injections of botulinum toxin with LA (BTX) or LA alone. The primary endpoint was Patient Global Impression of Improvement (PGI-I) score on day 60 after infiltration. Secondary endpoints were pain intensity, number of painful trigger points on palpation, analgesic drug consumption and quality of life.ResultsWe included 80 patients, 40 in each group. This study failed to demonstrate a significant difference between the 2 groups on day 60 in the primary endpoint or secondary endpoints (PGI-I score≤2=20% [LA] versus 27.5% [BTX], P=0.43). However, both groups showed significant alleviation of global pain.ConclusionThis study does not justify the use of botulinum toxin in the context of chronic pelvic pain with myofascial syndrome but does justify muscle injections with LA alone. ClinicalTrials.gov: NCT01967524.Copyright © 2020 The Authors. Published by Elsevier Masson SAS.. All rights reserved.

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