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: moderate

Author Information

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

Primary Institution: Radboud University Medical Center

Hypothesis

Women with chronic pelvic pain receiving Botulinum Toxin A injections in combination with pelvic floor muscle therapy will experience greater reductions in pain and improvements in quality of life compared to those receiving placebo injections with pelvic floor muscle therapy.

Conclusion

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

Supporting Evidence

  • 33% of women in the BTA group reported at least a 33% reduction in pain.
  • 17% of women in both groups reported being 'much better' or 'very much better'.
  • Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo.

Takeaway

The study tested if a special injection could help women with pelvic pain feel better, but it didn't really work better than a fake injection.

Methodology

Participants received either Botulinum Toxin A or placebo injections into the pelvic floor muscle, followed by pelvic floor muscle therapy 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 placebo effects.

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

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication