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

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Prostatic Hyperplasia, Benign; Prostate Adenoma; Lower Urinary Tract Symptoms

Treatments: Procedure: Monopolar enucleation of the prostate; Procedure: Ho:YAG laser enucleation of the prostate; Procedure: Thulium-fiber laser enucleation of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT03230721

IMSechenovMMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: Male

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

ThuLEP group

Active Comparator group

Description:

Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.

Treatment:

Procedure: Thulium-fiber laser enucleation of the prostate

Monopolar enucleation group

Active Comparator group

Description:

Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.

Treatment:

Procedure: Monopolar enucleation of the prostate

HoLEP group

Active Comparator group

Description:

Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.

Treatment:

Procedure: Ho:YAG laser enucleation of the prostate