ClinicalTrialsFinder
RecruitingNot ApplicableNCT06839768

Safety and Efficacy of MILEP Versus Standard EEP

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

Sponsor

Sechenov University

Enrollment

340 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

  • LUTS presence, proven by:
  • IPSS questionnaire (Score \>20);
  • OR uroflowmetry result (Qmax \<10 ml/s);

Exclusion Criteria6

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREStandard 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.

PROCEDUREMiLEP

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.

Locations(1)

Institute for Urology and Reproductive Health, Sechenov University

Moscow, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06839768

Related Trials

Stone and Laser Therapies Post-Market Study (SALT)

NCT069822355 locations

Early Versus Delayed Trial Without Catheter in Men With Acute Urinary Retention.

NCT0728348411 locations

Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.

NCT054010321 location