NCT06839768

Safety and Efficacy of MILEP Versus Standard EEP

The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Sechenov University · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures. Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).

Conditions

• Benign Prostate Hypertrophy(BPH)
• LUTS(Lower Urinary Tract Symptoms)

Interventions

Type	Name	Description
PROCEDURE	Standard endoscopic enucleation of the prostate (EEP)	Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.
PROCEDURE	MiLEP	Minimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

Timeline

• Start date: 2024-03-14
• Primary completion: 2025-03-01
• Completion: 2025-05-01
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: Russia