Actively Recruiting
The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
Led by Sechenov University · Updated on 2025-02-21
340
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Sechenov University
Lead Sponsor
H
Hospital Pompeia
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Safety and Efficacy of MILEP Versus Standard EEP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 85 years
- Presence of lower urinary tract symptoms (LUTS) confirmed by either an International Prostate Symptom Score (IPSS) greater than 20 or a urine flow rate (Qmax) less than 10 ml/s
You will not qualify if you...
- Prostate volume greater than 120 cc
- Diagnosis of prostate cancer on pathology
- Presence of urethral strictures
- Presence of bladder calculi
- History of prior prostate surgery
- Neurogenic bladder dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 to 2 days
Participants undergo either minimally-invasive laser enucleation of the prostate (MiLEP) or standard endoscopic enucleation of the prostate (EEP), followed by immediate post-operative care including monitoring of blood loss, catheterization, and hospital stay.
1 surgical procedure and hospital stay lasting about 1.5 days
Duration - Up to 12 months
Participants are followed after surgery to monitor recovery, adverse events, and assess urinary and sexual function.
Visits on the day of operation, and at 1, 6, and 12 months post-operative for assessments including urinary symptom scores and erectile function
Trial Site Locations
Total: 1 location
1
Institute for Urology and Reproductive Health, Sechenov University
Moscow, Russia, 119435.
Actively Recruiting
Research Team
V
Vladislav Petov, Associate Professor, urologist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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