The Efficacy of Botulinum Toxin A Injection in Pelvic Floor Muscles in Chronic Pelvic Pain Patients: A Double-Blinded Randomised Controlled Trial.

Objective: To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP).

Design: Randomised, double-blinded clinical trial (January 2020-April 2023).

Setting: This multicentre study was conducted at four hospitals in the Netherlands.

Population And Sample: Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled.

Methods: Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions.

Main Outcomes And Measures: Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis.

Results: A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72-4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32-2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001).

Conclusion: The results from this study do not support the use of BTA injections in the management of CPP in women.