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Firoozeh Raisi, MD , Firoozeh Raisi, MD Formal analysis, Supervision, Validation, Writing - review & editing Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran 13337-15914 , Iran Search for other works by this author on: Oxford Academic Robabeh Soleimani, MD Conceptualization, Formal analysis, Supervision, Validation, Visualization, Writing - original draft, Writing - review & editing Kavosh Cognitive Behavior Sciences and Addiction Research Center, Department of Psychiatry, School of Medicine, Guilan University of Medical Sciences , Rasht 41936-55599, Iran Corresponding author: Kavosh Cognitive Behavior Sciences and Addiction Research Center, Department of Psychiatry, School of Medicine, Guilan University of Medical Sciences, Rasht 41936-55599, Iran. Email: [emailprotected] Search for other works by this author on: Oxford Academic Azin Ahmadzadeh, MD Data curation, Resources, Visualization, Writing - review & editing Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran 13337-15914 , Iran Search for other works by this author on: Oxford Academic Seyedeh Nasibeh Sadati, MD Conceptualization, Data curation, Resources, Visualization, Writing - review & editing Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences , Sari 48431-85774, Iran Search for other works by this author on: Oxford Academic Arghavan Fakhrian, MD Conceptualization, Data curation, Resources, Visualization, Writing - review & editing Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran 13337-15914 , Iran Search for other works by this author on: Oxford Academic Mir Mohammad Jalali, MD Data curation, Resources, Validation, Writing - review & editing Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, School of Medicine, Amiralmomenin hospital, Guilan University of Medical Sciences , Rasht 41396-38459 , Iran Search for other works by this author on: Oxford Academic
https://orcid.org/0000-0003-1463-0380 The Journal of Sexual Medicine, qdaf094, https://doi.org/10.1093/jsxmed/qdaf094
Published:
06 May 2025
Article history
Received:
09 January 2025
Revision received:
24 March 2025
Accepted:
07 April 2025
Published:
06 May 2025
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Firoozeh Raisi, Robabeh Soleimani, Azin Ahmadzadeh, Seyedeh Nasibeh Sadati, Arghavan Fakhrian, Mir Mohammad Jalali, Efficacy and safety of pharmacological treatments in patients with premature ejaculation: an umbrella review of meta-analyses of randomized controlled trials, The Journal of Sexual Medicine, 2025;, qdaf094, https://doi.org/10.1093/jsxmed/qdaf094
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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. The primary outcome of interest was IELT. Effect sizes from primary studies of all SR-MAs were extracted, and after removing overlapping RCTs, a re-meta-analysis was conducted. We appraised evidence certainty using the Grading of recommendations, Assessment, Development, and Evaluations scoring system (GRADE).
Results
This review included 44 SR-MAs covering 65 RCTs. Only two SR-MAs rated as moderate to high quality in the AMSTAR-2 assessment. Additionally, only six out of 65 RCTs had a low risk of bias. The median follow-up for included RCTs was 7.9months. These treatments significantly improved IELT compared to placebo, with paroxetine achieving the largest mean difference (5.64min; 95% confidence interval [CI]: 3.50 to 9.07). However, all pharmacological treatments were associated with adverse events, with paroxetine having the lowest risk (RR: 1.5; 95% CI: 0.3 to 7.3), while risk ratios were higher for other treatments, including 4.1 for topical anesthetics, 2.4 for tramadol, and 1.8 for dapoxetine. Only topical anesthetics and paroxetine demonstrated a moderate to high rating in the GRADE assessment.
Conclusion
Topical anesthetics, tramadol, and SSRIs significantly increase IELT. However, substantial heterogeneity among meta-analyses may limit the robustness of these findings. Future RCTs should include extended follow-up periods to better assess the long-term efficacy and safety of these treatments.
PROSPERO registration number
CRD 42024561480.
premature ejaculation, drug therapy, umbrella review, meta-analysis
© The Author(s) 2025. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. For permissions, please e-mail: [emailprotected]
This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/pages/standard-publication-reuse-rights)
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