Simenafil, a newly developed oral phosphodiesterase type 5 (PDE5) inhibitor, substantially improves erectile function; however, its efficacy has not been evaluated via RigiScan monitoring. This study evaluated the efficacy and safety of simenafil in erectile dysfunction (ED) using audiovisual sexual stimulation. A randomized, double-blind, placebo-controlled, multicenter, two-cohort, three-way crossover study was conducted in 84 men aged 18-65 years with mild-to-moderate ED of ≥6 months. Each patient received placebo, simenafil 5.0 mg, and simenafil 2.5 mg (Cohort A, n = 42) or 10.0 mg (Cohort B, n = 42) administered in random order at least 5 days apart. RigiScan was used to assess the time to achieve and duration of ≥60% penile rigidity. In Cohort A, relative to placebo, 2.5 mg simenafil (single-dose) led to a least square mean (LSM) increase in the duration of ≥60% penile rigidity of 3.1 min (95% confidence interval [CI]: 0.5-5.7 min, P = 0.021) and 8.3 min (95% CI: 3.5-13.2 min, P = 0.001) at the tip and base, respectively; for the 5.0 mg, it was 3.7 min (95% CI: 1.0-6.4 min, P = 0.008) and 8.5 min (95% CI: 3.5-13.5 min, P = 0.001) at the tip and base, respectively. In Cohort B, the LSM duration of ≥60% rigidity of the penile base was significantly longer with 10.0 mg simenafil than with placebo by 5.9 min (95% CI: 0.8-10.9 min, P = 0.023). The 5.0 mg (tip and base) and 10.0 mg (tip) simenafil were not statistically significant compared with the placebo (all P > 0.05). The pharmacodynamic and safety profiles support simenafil as a suitable candidate for further investigation in ED.

Surgical treatments for benign prostatic hyperplasia (BPH) often impair sexual function. The 450 nm blue laser, with its high hemoglobin absorption and shallow penetration, offers rapid tissue vaporization while preserving sexual function. This study aims to evaluate the efficacy and safety of our blue laser vaporization technique, with a focus on preserving erection and antegrade ejaculation. This prospective cohort study enrolled 105 consecutive sexually active men (≥2 episodes/mo) with BPH who underwent transurethral blue laser vaporization between January 2023 and December 2023. The primary outcomes were the International Prostate Symptom Score (IPSS) and International Index of Erectile Function-5 (IIEF-5) at 12 mo. The median age, prostate volume, and operation time were 63 yr, 44 ml, and 25 min, respectively. The IPSS decreased from 24 to 8 (p < 0.001), and the maximum urinary flow rate (Qmax) increased from 9 ml/s to 25 ml/s (p < 0.001). Erectile function was preserved (IIEF-5: 18 vs 18, p = 0.479). Although ejaculate volume decreased (2.0 ml to 1.0 ml, p < 0.001), anejaculation occurred in only 2.8% of the patients. Transient hematuria occurred in 31.4% of the patients; 1 patient (1.0%) required reoperation for hemostasis. There were no new cases of erectile dysfunction or incontinence. The blue laser vaporization technique effectively and efficiently improves voiding outcomes through rapid prostate vaporization while preserving erectile function and antegrade ejaculation.