Safety and Efficacy of MILEP Versus Standard EEP

Last updated: February 17, 2025
Sponsor: Sechenov University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Interstitial Cystitis

Prostate Disorders

Treatment

Standard endoscopic enucleation of the prostate (EEP)

MiLEP

Clinical Study ID

NCT06839768
MILEP2024_0.1
  • Ages 18-85
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

LUTS presence, proven by:

  1. IPSS questionnaire (Score >20);

  2. OR uroflowmetry result (Qmax <10 ml/s);

Exclusion

Exclusion Criteria:

  • Prostate volume > 120 cc

  • Prostate cancer on pathology;

  • Urethral strictures;

  • Bladder calculi;

  • Prior prostate surgery;

  • Neurogenic bladder dysfunction.

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: Standard endoscopic enucleation of the prostate (EEP)
Phase:
Study Start date:
March 14, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Institute for Urology and Reproductive Health, Sechenov University

    Moscow, 119435.
    Russian Federation

    Active - Recruiting

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