Clinical trial NCT03230721: ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH
Official title: Comparative Analysis of the Efficacy and Safety of Thulium-fiber Laser Enucleation, Ho:YAG Laser Enucleation and Monopolar Enucleation in Management of BPH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia, Benign
Prostate Adenoma
Lower Urinary Tract Symptoms
Keywords: laser
HoLEP
ThuLEP
Thulium
Thulium-fiber
BPH
EEP
monopolar enucleation
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 450
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IPSS
timeFrame: Six months
Secondary outcomes:
measure: QoL
timeFrame: Six months
measure: PVR
timeFrame: Six months
measure: Qmax
timeFrame: Six months
measure: IIEF-5
timeFrame: Six months
Other outcomes:
Locations:
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Dmitry Enikeev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
citation: Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
citation: Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10.