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.