Botulinum Toxin for Pelvic Pain in Women With Endometriosis

Summary

Background: \- Some women with endometriosis have chronic pelvic pain. This pain may be caused by spasms of the pelvic floor muscles. These spasms can be detected by an examination. Studies suggest that botulinum toxin can help treat problems caused by muscle spasms. Researchers want to see if botulinum toxin injections into the pelvic floor muscles can decrease pain and spasms in women with pelvic pain. Objectives: \- To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic pain. Eligibility: \- Women between 18 and 50 years of age with pain associated with pelvic muscle spasm and endometriosis. Pain must be persistent (lasting for at least 3 months). Design: * Participants will keep a pain diary and record their pain medication use for a month before the first visit. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Participants will also answer questions about their pain levels and quality of life. * Participants will receive either botulinum toxin or a placebo (salt water) injection. The injection will be given into the pelvic floor muscles through the vaginal wall. Participants will take a muscle relaxant like Valium and have anesthetic cream put on the vaginal wall before the injection. * After the injection, participants will keep a pain diary for another month. * At a 1-month followup visit, participants will answer questions about their pain. If the pain has not improved, all participants may have a botulinum toxin injection (no placebo) into the pelvic floor muscles as before. * Participants will have followup visits for up to a year after the initial 1-month followup visit.

Timeline

Start

2014-07-30

Primary completion

2018-07-31

Completion

2019-07-24

Publications

• Background Abbott JA, Jarvis SK, Lyons SD, Thomson A, Vancaille TG. Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):915-23. doi: 10.1097/01.AOG.0000237100.29870.cc.
• Background Bhidayasiri R, Truong DD. Expanding use of botulinum toxin. J Neurol Sci. 2005 Aug 15;235(1-2):1-9. doi: 10.1016/j.jns.2005.04.017.
• Background Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702.
• Karp BI, Tandon HK, Sinaii N, Aredo JV, Phan VT, Salmeri N, Shah JP, Merideth MA, Stratton P. Botulinum toxin for endometriosis-associated chronic pelvic pain: a randomised, double-masked, parallel, phase 2 trial. EClinicalMedicine. 2026 Jan 5;91:103740. doi: 10.1016/j.eclinm.2025.103740. eCollection 2026 Jan.
• Phan VT, Stratton P, Tandon HK, Sinaii N, Aredo JV, Karp BI, Merideth MA, Shah JP. Widespread myofascial dysfunction and sensitisation in women with endometriosis-associated chronic pelvic pain: A cross-sectional study. Eur J Pain. 2021 Apr;25(4):831-840. doi: 10.1002/ejp.1713. Epub 2021 Jan 8.
• Tandon HK, Stratton P, Sinaii N, Shah J, Karp BI. Botulinum toxin for chronic pelvic pain in women with endometriosis: a cohort study of a pain-focused treatment. Reg Anesth Pain Med. 2019 Jul 8:rapm-2019-100529. doi: 10.1136/rapm-2019-100529. Online ahead of print.

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