Abstract
Objective: Assess effects of botulinum toxin for chronic pelvic pain in endometriosis.
Background: Pelvic pain often persists despite optimal surgical/hormonal management in women with endometriosis, often associated with pelvic floor spasm. We report the outcome of onabotulinumtoxinA (onaBoNTA) injection into pelvic floor muscles in women with endometriosis-associated chronic pelvic pain (endo-CPP).
Design/Methods: Women in an ongoing placebo-controlled trial of onaBoNTA for endo-CPP were offered an open toxin injection at any time between one-month to one-year following the masked, randomized study injection. We assessed change in spasm, pain, and disability in those choosing open injection.
With conscious sedation and topical anesthetic, 100units onaBoNTA (25units/cc) was injected transvaginally into areas of pelvic floor muscle spasm under EMG guidance. Spasm was assessed by pelvic exam. Pain, disability, and pain medication use were assessed by patient diaries, visual analog scale (VAS), and validated questionnaires before and after injection.
Results: Ten of 13 women in the randomized trial requested open toxin injection and were followed for >3 months post-injection.
At baseline, 8/10 had spasm in at least 4/6 assessed pelvic muscles and intense pain (median VAS 6.5 of 10; range: 2–8). On exam at least 1-month post-injection, spasm was absent/less widespread (≤3 muscles) in all (p=0.0001). 8/10 rated their pain as absent/mild (median VAS 1.5; range: 0–5; p=0.0001); 5/10 reduced their pain medication usage. Disability assessed by Oswestry Disability Questionnaire decreased in 3 of 5 women with at least moderate disability pre-injection. At study evaluation 6–11-months post-injection, 3 of 10 reported return of pain and requested additional injection. Adverse events were mild and transient.
Conclusions: Pelvic floor spasm appears to be a major contributor to pain in some women with endo-CPP. In this open study, injection of onaBoNTA reduced pain, spasm, and disability for up to 11 months. Utility of botulinum toxin for endo-CPP merits evaluation in controlled clinical trials.
Study Supported by: The NIH Intramural Research Program.
Disclosure: Dr. Karp has received research support from Allergan, Merz. Dr. Tandon has nothing to disclose. Dr. Sinaii has nothing to disclose. Dr. Shah has nothing to disclose. Dr. Stratton has nothing to disclose.
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