Health TrialsbyHealthPanel

Safety and Efficacy of MILEP Versus Standard EEP

ConditionsBenign Prostate Hypertrophy(BPH)LUTS(Lower Urinary Tract Symptoms)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-85
SponsorSechenov University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

IPSS questionnaire (Score >20);

OR uroflowmetry result (Qmax <10 ml/s);

Disqualifiers

Prostate volume > 120 cc

Prostate cancer on pathology;

Urethral strictures;

Bladder calculi;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard endoscopic enucleation of the prostate (EEP)

    Procedure/Surgery

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

  • MiLEP

    Procedure/Surgery

    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.

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: MiLEP (22 Ch)Experimental treatment 1 intervention
Group B: EEP (26 Ch)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The rate of SUI

Time frame
1 month

Secondary outcomes

1

Rate of urethral strictures

Time frame
6-12 months
2

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
3

Operative time

Time frame
participants will be followed for the duration of the intervention, an expected average of 1 hour
4

Blood loss (blood levels of haemoglobin and haematocrit)

Time frame
1 day before and 1 day after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sechenov University

Lead sponsor

Hospital Pompeia

Collaborator

Source ClinicalTrials.gov
Apply now