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Safety and Efficacy of MILEP Versus Standard EEP

NCT06839768 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-02-21

No results posted yet for this 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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Pompeia

    collaborator OTHER

  • Sechenov University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2025-03-31
Completion
2025-05-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839768 on ClinicalTrials.gov