Comparison of Safety and Effectiveness of Minimally-invasive MiLEP Versus Standard Laser Enucleation of the Prostate for Treating Benign Prostate Enlargement

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a minimally-invasive laser technique called MiLEP compared to the standard endoscopic enucleation of the prostate EEP for men with benign prostatic hyperplasia BPH and lower urinary tract symptoms LUTS. MiLEP uses smaller surgical instruments, which may reduce complications like stress urinary incontinence and urethral strictures. This prospective randomized trial aims to compare both treatments using a thulium fiber laser TFL. The trial includes two groups one receiving the MiLEP procedure with a 22 Ch resectoscope and the other undergoing the standard EEP using a 26 Ch resectoscope. Both procedures involve en bloc no-touch enucleation with early apical release. The intervention is expected to last about one hour, followed by catheterization and hospital stay averaging 1.5 days. Patients are randomly assigned to one of the two treatment groups. Participants will be monitored for outcomes including the rate of stress urinary incontinence one month after surgery, urethral strictures within 6 to 12 months, and any intra- or perioperative adverse events up to 12 months post-operation. Additional assessments include operative time, blood loss before and after surgery, catheterization duration, hospital stay length, symptom scores, urine flow rates, residual urine volume, and erectile function. The total study period extends to 12 months post-surgery to evaluate safety and effectiveness.

Safety and Efficacy of MILEP Versus Standard EEP