Silodosin versus Dapoxetine in the Treatment of Mono-Symptomatic Premature Ejaculation: A Randomized Comparative Study
Abstract
Background: Premature ejaculation (PE) negatively affects quality of life and is commonly managed with on-demand dapoxetine. Silodosin (an α1-adrenoceptor antagonist) has been reported to prolong intravaginal ejaculatory latency time (IELT) as an adverse effect. Aims: To compare the safety and efficacy of silodosin 4 mg versus dapoxetine 30 mg for mono-symptomatic PE. Patients and Methods: Prospective, open-label, randomized, parallel-group study conducted at Al-Azhar University Hospitals (March 2024–April 2025). Of 150 enrolled patients, 145 completed the study (silodosin group n=73; dapoxetine group n=72). Treatments were given on demand for 8 weeks. Primary outcomes: IELT, Premature Ejaculation Diagnostic Tool (PEDT). Secondary outcomes: International Index of Erectile Function (IIEF-5), sexual satisfaction score (SS), and adverse events. Data were analyzed using t-tests and chi-square; p<0.05 was considered significant. Results: Both groups showed significant improvement from baseline in IELT and PEDT (p<0.001). Post-treatment mean IELT was 6.42 ± 3.23 min (silodosin) and 7.97 ± 3.26 min (dapoxetine), p=0.005. Post-treatment PEDT scores were 6.26 ± 4.31 and 4.64 ± 2.8, respectively (p=0.009). Dapoxetine produced larger percentage changes in IELT and PEDT (Δ IELT% 542.6 ± 336.7 vs 345.4 ± 270.7, p<0.001; Δ PEDT% -65.9 ± 20.9 vs -53.7 ± 32.3, p=0.008). Overall adverse event rates were similar (35.6% vs 30.6%, p=0.517); silodosin was associated mainly with decreased semen…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 150 participants or records.
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