Safety and Efficacy of MILEP Versus Standard EEP

Sechenov University340 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

340

Conditions

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

Interventions

Standard endoscopic enucleation of the prostate (EEP)PROCEDURE

Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

MiLEPPROCEDURE

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

The rate of SUI

Time frame: 1 month

Secondary Outcomes

Rate of urethral strictures

Time frame: 6-12 months

Rate of intra- and perioperative adverse events

Assessed using Clavien-Dindo classification system

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)

Mild LUTS (symptom score less than of equal to 7) Moderate LUTS (symptom score range 8-19) Severe LUTS (symptom score range 20-35)

Time frame: 1 month

Qmax

Time frame: 1 month

PVR

Time frame: 1 month

Central Contacts

Vladislav Petov, Associate Professor, urologist

CONTACT

+7 925 351 75 49 pettow@mail.ru

Data from ClinicalTrials.gov

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