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Efficacy and safety of botulinum toxin-A injection in the treatment of premature ejaculation: A systematic review and meta-analysis

Yicheng Guo, Fengze Sun, Yini Wang, Yanfei Li, Tianqi Wang, Xiaohong Ma, Jitao Wu

PLoS ONE, 2025

3 citations

Abstract

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 0.05). 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…

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