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

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230721
• Other study ID #: IMSechenovMMA
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: July 26, 2017
• Start date: January 15, 2015
• Est. completion date: July 21, 2017

Study information

• Verified date: July 2017
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 21, 2017
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Thulium-fiber laser enucleation of the prostate
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.
• Monopolar enucleation of the prostate
Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.
• Ho:YAG laser enucleation of the prostate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

References & Publications (3)

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):1066-96. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25. Review. — View 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 May 10:0. doi: 10.5301/uj.5000232. [Epub ahead of print] — View Citation

Gravas S B. T., Bachmann A, Drake M, Gacci M, Gratzke C, et al. Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO) // EAU Guidelines on. Eur Assoc Urol. 2016.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS	International Prostate Symptom Score	Six months
Secondary	QoL	Quality of Life Score	Six months
Secondary	PVR	Post-void residual volume	Six months
Secondary	Qmax	Maximal urine flow rate	Six months
Secondary	IIEF-5	The International Index of Erectile Function	Six months