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.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
The results of a well-designed and conducted RCT are always important regardless of the direction of the results. It is a pity that no beneficial effect was found for a common clinical condition such as chronic pelvic pain, but honest results are welcome. In this case, the results indicate not to use this treatment so as not to create false expectations for these women.
Ms. Heather Taylor (12/11/2024 1:25 PM)
This is a well designed study. Both the treatment and control groups received pelvic floor physiotherapy, which was found to reduce pain scores and improve function.
A statistically significant decrease was found in pelvic floor muscle resting activity for the group receiving the Botox injection; however, this did not correlate to a decrease in pain. This finding points to the need for further understanding of the mechanisms of pelvic girdle pain, particularly following a biopsychosocial approach. The authors point to this issue in the study and recommend better defined patient subgroups.
, McMaster University