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Recruiting NCT06839768

Safety and Efficacy of MILEP Versus Standard EEP

No phase Interventional Benign Prostate Hypertrophy(BPH) LUTS(Lower Urinary Tract Symptoms)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard endoscopic enucleation of the prostate (EEP), MiLEP.
Who it may be relevant to
Registry conditions: Benign Prostate Hypertrophy(BPH), LUTS(Lower Urinary Tract Symptoms). Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Primary outcome measures

  • The rate of SUI [Time frame: 1 month]
Secondary outcome measures (10)
  • Rate of urethral strictures [Time frame: 6-12 months]
  • Rate of intra- and perioperative adverse events [Time frame: the day of operation, at 1, 6,12 months post-operative]
  • Operative time [Time frame: participants will be followed for the duration of the intervention, an expected average of 1 hour]
  • Blood loss (blood levels of haemoglobin and haematocrit) [Time frame: 1 day before and 1 day after surgery]
  • Catheterization time [Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days]
  • Hospital stay [Time frame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days]
  • International Prostate Symptom Score (IPSS) [Time frame: 1 month]
  • Qmax [Time frame: 1 month]
  • PVR [Time frame: 1 month]
  • International Index of Erectile Function (IIEF-5) [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Institute for Urology and Reproductive Health, Sechenov University — Moscow

Identifiers

NCT: NCT06839768 · MILEP2024_0.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗