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

NCT03230721 | Completed DMC

• 1 other identifier: IMSechenovMMA
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

laser; HoLEP; ThuLEP; Thulium; Thulium-fiber; BPH; EEP; monopolar enucleation

Outcome Measures

Primary Outcomes (1)

• IPSS

  International Prostate Symptom Score

  Six months

Secondary Outcomes (4)

• QoL

  Six months

• PVR

  Six months

• Qmax

  Six months

• IIEF-5

  Six months

Study Arms (3)

ThuLEP group

ACTIVE COMPARATOR

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

Procedure: Thulium-fiber laser enucleation of the prostate

Monopolar enucleation group

ACTIVE COMPARATOR

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

Procedure: Monopolar enucleation of the prostate

HoLEP group

ACTIVE COMPARATOR

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

Procedure: Ho:YAG laser enucleation of the prostate

Interventions

Thulium-fiber laser enucleation of the prostate PROCEDURE

A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.

Also known as: ThuLEP

ThuLEP group

Monopolar enucleation of the prostate PROCEDURE

Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.

Also known as: Monopolar enucleation

Monopolar enucleation group

Ho:YAG laser enucleation of the prostate PROCEDURE

Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.

Also known as: HoLEP

HoLEP group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Related Publications (3)

• 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.

  PMID: 25613154 BACKGROUND

• 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.

  PMID: 24972732 BACKGROUND

• 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.

  PMID: 28497447 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitry Enikeev, MD, PhD

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Sсience, Dept. of Urology, I.M. Sechenov Moscow State Medical University

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: January 15, 2015
• Primary Completion: April 22, 2017
• Study Completion: July 21, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share