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Efficacy and safety of on-demand dapoxetine combined with phosphodiesterase-5 inhibitor compared to monotherapy dapoxetine as a treatment of premature ejaculation without erectile dysfunction: a systematic review and meta-analysis

Mahesvara IBGA, Suarsana IW, Putra IBOW, Manuaba IBKP

Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica, 2025

498 participants

Abstract

BACKGROUND

Premature ejaculation (PE) affects about 30% of the male population. The European Association of Urology (EAU) guidelines state that monotherapy dapoxetine on-demand has been successfully used to treat PE throughout Europe. Several studies have stated that when dapoxetine and phosphodiesterase-5 inhibitor (PDE-5i) are used combined, sexual enjoyment and intravaginal ejaculation latency time (IELT) are increased more than when dapoxetine is taken alone. However, further investigation is needed to determine whether PDE-5i and dapoxetine can be safely consumed together.

METHODS

This study was conducted using 5 randomized controlled trials (RCTs), which systematically extracted from online databases, namely Science Direct, PubMed, Google Schoolar and Cochrane Library. Included studies were assessed using Cochrane Risk of Bias (RoB) 2.0 for RCTs. The data analysis was performed using RevMan software 5.1 of the Cochrane Collaboration.

RESULTS

Five RCTs with a total of 498 potent men with PE from the period 2013-2024 showed pooled mean difference of dapoxetine + PDE-5i was found significantly associated with higher post-treatment IELT scores compared to monotherapy dapoxetine (MD 1.08; 95% CI 0.34-1.83; p=0.004; I2 = 95%; 4 RCTs). The pooled mean difference of dapoxetine + PDE-5i also showed statistically significant association with higher post-treatment sexual satisfaction scale (SSS) scores compared to monotherapy dapoxetine (MD 0.76; 95% CI 0.49-1.04; p<0.00001; I2 =…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 498 participants or records.

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