The Efficacy of Botulinum Toxin A Injection in Pelvic Floor Muscles in Chronic Pelvic Pain Patients: A Double‐Blinded Randomised Controlled Trial
2024

Botulinum Toxin A for Chronic Pelvic Pain

Sample size: 94 publication Evidence: low

Author Information

Author(s): Melle A. Spruijt, Wenche M. Klerkx, Kim Notten, Hugo van Eijndhoven, Leonie Speksnijder, Manon H. Kerkhof, Kirsten B. Kluivers

Primary Institution: Radboud University Medical Center

Hypothesis

Women with chronic pelvic pain receiving BTA injections in combination with PFMT will experience greater reductions in pain and improvements in quality of life compared to those receiving placebo injections with PFMT.

Conclusion

The results from this study do not support the use of BTA injections in the management of chronic pelvic pain in women.

Supporting Evidence

  • 33% of participants in the BTA group reported a 33% reduction in pain compared to 20% in the placebo group.
  • Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo.
  • Both groups showed similar changes in average pain scores over the 26-week follow-up.

Takeaway

This study looked at whether a special injection could help women with pelvic pain feel better. It found that the injection didn't really help more than a fake one.

Methodology

Participants received either BTA injections or placebo injections into the pelvic floor muscle, followed by four PFMT sessions.

Potential Biases

Envelope randomisation may introduce bias, although baseline characteristics were similar between groups.

Limitations

The study was affected by the COVID-19 pandemic, which led to cancellations of follow-up visits and potential biases in the results.

Participant Demographics

The study included 94 women with chronic pelvic pain, median age 47 years, predominantly Caucasian.

Statistical Information

P-Value

0.19

Confidence Interval

95% CI 0.72–4.90

Statistical Significance

p=0.19

Digital Object Identifier (DOI)

10.1111/1471-0528.17991

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