(483) High-Intensity Laser Therapy for Erectile Dysfunction: Real-World Outcomes from a Standardized Protocol

Abstract Introduction Erectile dysfunction (ED) is prevalent, and 30–35% of patients have suboptimal response or intolerance to phosphodiesterase-5 inhibitors (PDE5i). High-Intensity Laser Therapy (HILT), a class-IV photobiomodulation modality, may enhance erectile physiology via mitochondrial activation, nitric-oxide signaling, and vascular/neural effects. Human evidence remains limited, with heterogeneous protocols and inconsistent outcome reporting. Objective To assess effectiveness and safety of a standardized HILT regimen on erectile rigidity measured by the Erection Hardness Score (EHS; 1–4) in routine outpatient practice. Methods This was a retrospective chart-review cohort at a single-centre outpatient andrology clinic. Consecutive men aged 25–50 years with ED who completed 8 HILT sessions over 4 weeks (twice weekly) were included. Per session, the penile shaft received 1000 J at 3 W and the crura 1500 J at 5 W in continuous mode using a class-IV near-infrared device. PDE5i were withheld ≥4 weeks before and during treatment. EHS was analyzed on the international 1–4 scale. The primary efficacy set excluded men with baseline EHS=4; the full analysis set (ALL) included all patients with complete pre/post EHS. Pre→post change was evaluated with paired t-tests (two-sided α=0.05); 95% confidence intervals (CIs) and Cohen’s d (paired) were reported. A responder was defined as post-treatment EHS=4. Adverse events (AEs) were extracted from charts. The study used de-identified records and institutional approval/waiver. Results ALL (n=150): mean EHS increased from 2.32±0.89 to 3.84±0.37 (Δ +1.52, 95% CI 1.38– 1.66; paired t(149)=21.53, p0.0001; Cohen’s d=1.76). Responders: 126/150 (84.0%) achieved EHS=4. Primary efficacy (baseline EHS ≤3; n=136): mean EHS improved from 2.15±0.75 to 3.82±0.38 (Δ +1.68, 95% CI 1.55–1.80; paired t(135)=26.10, p0.0001; d=2.24). Responders: 112/136 (82.35%) reached EHS=4. Safety: No serious AEs were documented. Transient warmth/tingling occurred in some patients and resolved without intervention. No treatment discontinuations were recorded. Conclusions In a real-world outpatient clinic, a standardized HILT protocol was associated with large, statistically significant gains in erectile rigidity (EHS 1–4) and excellent tolerability among men aged 25–50 years. These results justify prospective, sham-controlled trials with standardized dosimetry and objective vascular endpoints to confirm causality and durability, and to define optimal candidacy and maintenance strategies. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: BHANDARI HEALTHCARE