ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH

Not Applicable

Completed

• Conditions: Prostatic Hyperplasia, Benign; Lower Urinary Tract Symptoms; Prostate Adenoma
• Interventions: Procedure: Monopolar enucleation of the prostate; Procedure: Thulium-fiber laser enucleation of the prostate

• Registration Number: NCT03230721
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands (\>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes and safety of different techniques of endoscopic enucleation of the prostate (monopolar enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.

Detailed Description

HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European Association of Urology for use in men with substantially enlarged prostates (\>80 ml) as first-line therapy \[1\]. This type of operation can be performed by means of several sources of energy.

To our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities.

In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis, USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial.

All peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.

Study Timeline

• Study Start: 2015-01-15
• Primary Completion: 2017-04-22
• Status Verified: 2017-07
• Study Completion: 2017-07-21
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-26
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

• IPSS>20;
• maximum urinary flow rate< 10ml\s (Qmax);
• ineffective alfa-blockers therapy.

Exclusion Criteria

• histologically verified prostate cancer;
• history of prostatic surgery;
• urethral strictures;
• bladder stones;
• chronic urinary retention and cystostomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monopolar enucleation group	Monopolar enucleation of the prostate	Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
ThuLEP group	Thulium-fiber laser enucleation of the prostate	Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.

Primary Outcome Measures

Name	Time	Method
IPSS	Six months	International Prostate Symptom Score

Secondary Outcome Measures

Name	Time	Method
QoL	Six months	Quality of Life Score
Qmax	Six months	Maximal urine flow rate
IIEF-5	Six months	The International Index of Erectile Function
PVR	Six months	Post-void residual volume