To evaluate the efficacy and safety of topical anesthetic agents for patients with premature ejaculation (PE).

Eligible randomized controlled trials (RCTs) were identified from electronic databases (Cochrane Central Register of Controlled Trials, Medline, and EMBASE) without language restrictions. The database search, quality assessment, and data extraction were performed independently by 2 reviewers. The main outcome for the efficacy of topical anesthetic agents was intravaginal ejaculatory latency time (IELT). Efficacy and safety were explored using Review Manager, version 5.1.0 (Cochrane Collaboration, Oxford, UK).

Eight trials met the inclusion criteria. Our pooled analysis showed that IELT in the topical anesthetic agent group was significantly improved compared to the placebo group (random-effect model; mean difference [MD] 5.82, 95% confidence interval [CI] 3.50-8.14, P <.00001). According to the subgroup analysis, a significant improvement was obtained in the domains of ejaculatory control, sexual satisfaction, and distress in the Index of Premature Ejaculation (IPE) questionnaire (random-effect model, MD 4.53, 95% CI 3.05-6.01, P <.00001). In terms of adverse events (AEs), the pooling outcome showed that the overall incidence of AEs was significantly higher in the topical anesthetic agent group than in the placebo group (random-effect model, relative risk [RR] 4.28, 95% CI 1.63-11.24, P = .003). However, nearly all of the AEs were mild and transient.

Topical anesthetic agents have been shown to be effective and well tolerated for patients with primary PE, providing a significant improvement in IELT with a higher incidence of AEs that were not long-lasting or severe. High-quality RCTs are necessary to confirm the efficacy and safety of topical anesthetics for PE.