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NCT Number: NCT06839768

Safety and Efficacy of MILEP Versus Standard EEP

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).

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Key information

Conditions

Benign Prostate Hypertrophy(BPH) Genital Diseases Genital Diseases, Male LUTS(Lower Urinary Tract Symptoms) Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Urology and Reproductive Health, Sechenov University

Moscow, 119435., Russia

Location status: Recruiting

Location contact

Vladislav Petov

CONTACT

[email protected]

+79253517549

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

LUTS presence, proven by:

  • IPSS questionnaire (Score >20);
  • 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.

Treatment and study plan

Standard endoscopic enucleation of the prostate (EEP)

Procedure

Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

MiLEP

Procedure

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.

Primary outcomes

  1. The rate of SUI

    Time frame: 1 month

Secondary outcomes

  1. Rate of urethral strictures

    Time frame: 6-12 months

  2. Rate of intra- and perioperative adverse events

    Time frame: the day of operation, at 1, 6,12 months post-operative

    Assessed using Clavien-Dindo classification system

  3. Operative time

    Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour

  4. Blood loss (blood levels of haemoglobin and haematocrit)

    Time frame: 1 day before and 1 day after surgery

  5. Catheterization time

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days

  6. Hospital stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days

  7. International Prostate Symptom Score (IPSS)

    Time frame: 1 month

    Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)

  8. Qmax

    Time frame: 1 month

  9. PVR

    Time frame: 1 month

  10. International Index of Erectile Function (IIEF-5)

    Time frame: 1 month

    severe ED (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21), and no ED (22-25)

Study contacts

Contact information is provided by the study sponsor or research team.

Vladislav Petov, Associate Professor, urologist

CONTACT

[email protected]

+7 925 351 75 49

Sponsors and collaborators

Lead sponsor

Sechenov University

Other

Collaborators

  • Hospital Pompeia

Registry information

Official study title

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

Acronym: MILES

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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