HoLEP Versus Mini-HoLEP: A Long-term Follow-up Prospective Randomized Controlled Trial

Background and objective Holmium laser enucleation of the prostate (HoLEP) is increasingly performed with miniaturized instruments, aiming to reduce postoperative urinary incontinence (UI). Evidence for mini-HoLEP (MiLEP) using a 22-Fr resectoscope remains largely retrospective or nonrandomized. We aimed to compare MiLEP with a standard 26 Fr HoLEP in a prospective randomized trial. Methods Ninety men were randomized to MiLEP ( n = 45) or HoLEP ( n = 45). All procedures were performed by one surgeon using a standardized technique. The prespecified primary end point was UI, defined as any reported loss of urine, at 1 mo. Key secondary end points included UI at 2 mo and at the end of follow-up. Key findings and limitations Median follow-up was 828 days. UI at 1 mo was lower after MiLEP than HoLEP (22.2% vs 51.1%; odds ratio [OR] 0.27; 95% confidence interval [CI] = 0.11–0.67; p = 0.004). UI at 2 mo was also lower (8.9% vs 24.4%; OR 0.30; 95% CI = 0.09–0.99; p = 0.048), whereas long-term UI did not differ significantly (2.2% vs 6.7%; p = 0.61). MiLEP also lowered the need for meatal dilation (15% vs 51%; p < 0.001), irrigation volume (16 vs 24 l; p < 0.001), and improved core temperature maintenance (+0.1 °C vs –0.1 °C; p < 0.001), with higher median enucleation efficiency (1.22 vs 1.0; p = 0.003) and not statistically different operative time, complications, and functional improvement. Limitations include the inability to blind the surgeon and limited power for uncommon events. Conclusions and clinical implications MiLEP seems to improve early continence recovery, supporting miniaturization as a strategy to enhance patient-centered outcomes after HoLEP.