Safety and Efficacy of MILEP Versus Standard EEP (MILES)

Sechenov University

Status: Enrolling

Conditions: Benign Prostate Hypertrophy(BPH); LUTS(Lower Urinary Tract Symptoms)

Treatments: Procedure: MiLEP; Procedure: Standard endoscopic enucleation of the prostate (EEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06839768

MILEP2024_0.1

Details and patient eligibility

About

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).

Enrollment: 340 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

LUTS presence, proven by:

1. IPSS questionnaire (Score >20);
2. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

MiLEP (22 Ch)

Experimental group

Treatment:

Procedure: MiLEP

EEP (26 Ch)

Active Comparator group

Treatment:

Procedure: Standard endoscopic enucleation of the prostate (EEP)