Purpose: To investigate the overall treatment efficacy and safety of botulinum toxin type A (BoNTA) injections compared with placebo in interstitial cystitis/bladder pain syndrome (IC/BPS).
Methods: We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and EMBASE on BoNTA use in IC/BPS. Outcome measures included changes of OLS, ICSI, ICPI, VAS, frequency, nocturia, FBC, Qmax, and PVR from baseline and also included adverse events.
Results: A total of five studies were included, with a total sample size of 252 subjects (133 subjects in the experimental group and 119 subjects in the control group). The duration of follow-up ranged from 8 to 12 weeks. The BoNTA dosage was from 50 to 200 U. The pooled overall SMD in the mean change of VAS for the BoNTA group versus the placebo group was -0.49 (95 % CI -0.74, -0.23). There were also significant improvements in ICPI and frequency. The other outcomes (ICSI, nocturia, Qmax, and FBC) were not statistically different between the two groups.
Conclusion: Although BoNTA is not regulatory approved indication, this first evidence-based systematic review and meta-analysis of BoNTA injection for IC/BPS showed significant differences in efficacy of treatment compared with placebo, especially for pain control, and also showed no differences in the rate of procedure-related adverse events.
Keywords: Bladder pain syndrome; Botulinum toxin; Interstitial cystitis; Meta-analysis; Placebo.