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Efficacy and safety of pharmacological treatments in patients with premature ejaculation: an umbrella review of meta-analyses of randomized controlled trials

Raisi F, Soleimani R, Ahmadzadeh A, Sadati SN, Fakhrian A, Jalali MM

The journal of sexual medicine, 2025

7 citations

Abstract

INTRODUCTION: Premature ejaculation (PE) is a common male sexual dysfunction characterized by short ejaculatory latency with minimal stimulation, an inability to delay or control ejaculation, and distress or dissatisfaction due to the condition. Pharmacological therapy is central to PE management, with dapoxetine as the only approved selective serotonin reuptake inhibitor (SSRI). Off-label options, including long-acting selective serotonin reuptake inhibitors (SSRIs) (eg, paroxetine), topical anesthetics, phosphodiesterase type 5 inhibitors (eg, sildenafil), and tramadol, have also been explored. Despite numerous systematic reviews on its treatment, challenges remain due to methodological heterogeneity, variability in outcome measures, and inconsistencies in trial quality, making it difficult to draw reliable conclusions.

OBJECTIVES: This umbrella review of systematic reviews and meta-analyses (SR-MAs) of randomized controlled trials (RCTs) examined the efficacy of pharmacological treatments in prolonging intravaginal ejaculatory latency time (IELT) and their safety by analyzing associated adverse events in adults with PE.

METHODS: A comprehensive search of SR-MAs ranging from 1990 to 2024 was performed. Two reviewers independently screened articles, extracted data, and assessed quality of previous SR-MAs using the A Measurement Tool to Assess Systematic Reviews version 2 (AMSTAR-2) tool and the risk of bias of RCTs using Cochrane's risk-of-bias tool for randomized trials.…

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