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The effect of topical and intraurethral alprostadil on erectile function: A systematic review and meta-analysis

Papadopoulos I, Tishukov M, Sokolakis I, Katafigiotis I, Leotsakos I, Karavitakis M, Marcon J, Stief CG et al.

Andrology, 2025

5,869 participants · 3 citations

Abstract

Background: Erectile dysfunction (ED) affects up to 50% of men over 40. While phosphodiesterase-5 inhibitors (PDE5i) are the first line of medical treatment, they are not always effective. Alprostadil, available in injectable, topical, and intraurethral forms, offers an alternative treatment modality.

Objectives: This systematic review and meta-analysis aim to evaluate the efficacy and safety of topical and intraurethral forms of alprostadil.

Materials and methods: The objectives and methods of this systematic review and meta-analysis were predefined in a protocol registered on PROSPERO (CRD42021260894). We systematically searched PubMed, EMBASE, and the Cochrane Library up to April 2024. Using a random-effects model, we compared the efficacy of topical and intraurethral forms of alprostadil against placebo. Additionally, we performed a qualitative assessment of the studies using RoB-2 and ROBINS-I tools.

Results: The analysis included 11 randomized controlled trials and 4 non-randomized studies, encompassing 5869 patients with a mean age of 60 ± 9.4 years. The meta-analysis showed a statistically significant improvement in the IIEF score by 4.7 points (95% CI: 2.4-7.1, I2 = 97%) in patients using the topical form of alprostadil compared to placebo. There was also a statistically significant improvement of ED in patients using intraurethral alprostadil compared to placebo, with a pooled odds ratio of 0.08 (95% CI: 0.04-0.16, I2 = 54%). The most common adverse events reported…

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: 5,869 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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