Safety and Efficacy of MILEP Versus Standard EEP (MILES)

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

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).

Study Overview

• Status: Recruiting
• Conditions: LUTS(Lower Urinary Tract Symptoms); Benign Prostate Hypertrophy(BPH)
• Intervention / Treatment: Procedure: MiLEP; Procedure: Standard endoscopic enucleation of the prostate (EEP)

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vladislav Petov, Associate Professor, urologist; Phone Number: +7 925 351 75 49; Email: pettow@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435.
    • Recruiting
    • Institute for Urology and Reproductive Health, Sechenov University
    • Contact: Vladislav Petov; Phone Number: +79253517549; Email: pettow@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

LUTS presence, proven by:

1. IPSS questionnaire (Score >20);
2. OR uroflowmetry result (Qmax <10 ml/s);

Exclusion Criteria:

• Prostate volume > 120 cc
• Prostate cancer on pathology;
• Urethral strictures;
• Bladder calculi;
• Prior prostate surgery;
• Neurogenic bladder dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MiLEP (22 Ch)	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.
Active Comparator: EEP (26 Ch)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of SUI	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay		participants will be followed for the duration of hospital stay, an expected average of 1,5 days
Rate of urethral strictures		6-12 months
Rate of intra- and perioperative adverse events	Assessed using Clavien-Dindo classification system	the day of operation, at 1, 6,12 months post-operative
Operative time		participants will be followed for the duration of the intervention, an expected average of 1 hour
Blood loss (blood levels of haemoglobin and haematocrit)		1 day before and 1 day after surgery
Catheterization time		participants will be followed for the duration of hospital stay, an expected average of 1,5 days
International Prostate Symptom Score (IPSS)	Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)	1 month
Qmax		1 month
PVR		1 month
International Index of Erectile Function (IIEF-5)	severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)	1 month

Collaborators and Investigators

• Sponsor: Sechenov University
• Collaborators: Hospital Pompeia

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urological Manifestations; Prostatic Hyperplasia; Hypertrophy; Lower Urinary Tract Symptoms
• Other Study ID Numbers: MILEP2024_0.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No