Introduction: Premature ejaculation (PE) is a common male sexual dysfunction, impacting sexual satisfaction and quality of life. Botulinum toxin-A (BoNT-A), known for its muscle-relaxing properties, has been proposed as a treatment for PE, but its efficacy and safety remain uncertain.
Objectives: To systematically evaluate the efficacy and safety of BoNT-A injection compared to placebo for treating PE.
Methods: A comprehensive search of PubMed, EMBASE, and Cochrane databases was conducted to identify randomized controlled trials comparing BoNT-A and placebo in treating PE. Primary outcomes included intravaginal ejaculatory latency time (IELT) and premature ejaculation profile (PEP), while sexual satisfaction score was a secondary outcome. Mean differences (MD) with 95% confidence intervals (CI) and odds ratios (OR) for adverse events were calculated using a random-effects model.
Results: Three studies were included in the analysis. BoNT-A significantly increased IELT and PEP at the 1-month follow-up (MD = 22.32; 95% CI = 10.83-33.82; P = 0.001 for IELT; MD = 0.91; 95% CI = 0.41-1.42; P < 0.001 for PEP), but no significant differences were observed at 3-month and 6-month follow-ups (P > 0.05). No significant improvements in sexual satisfaction were found (P = 0.32). BoNT-A was associated with a higher incidence of adverse events compared to placebo (OR = 5.90; 95% CI = 1.29-26.89; P = 0.02), but no significant differences were observed for drippling or erectile dysfunction (P > 0.05).
Conclusion: BoNT-A injections may be an effective short-term treatment for PE, significantly improving IELT and PEP at 1-month follow-up. However, the effects appear to diminish over time, and no significant improvement in sexual satisfaction was observed. BoNT-A is associated with a higher rate of adverse events, but does not increase the risk of drippling or erectile dysfunction. Further studies with longer follow-up periods are needed to assess long-term efficacy and safety.
Copyright: © 2025 Guo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.