Greenlight Laser for BPH – A Prospective international study on indications and outcomes

During the past two decades we are witnessing the incorporation of an increasing number minimal invasive treatments for Benign Prostatic Hyperplasia. Laser treatment is truly on the rise, most probably due to technical refinements of the technology and refinement of endoscopic equipment.
There are some fundamental (institutional) differences, however, concerning indication for surgery, experience, technique used and maybe outcomes. Moreover specific factors may influence treatment related morbidity. In this prospective study we will study on a global base the indications and outcomes of HPS greenlight laser treatment for BPH. Each centre participating in this project will include during a one-year period the patients treated at their site.

Download the HPS protocol

Primary study objective:

To assess the current indications for HPS greenlight laser treatment and the treatment outcomes in terms of objective and subjective improvement
   

Secondary study objectives:

To assess the peri-operative morbidity (30 days) by using the Clavien system.

To define risk factors for the development of peri-operative morbidity after HPS greenlight laser treatment.

The following variables will be included to correlate in a logistic regression and uni/multivariate analysis:

The use of antibiotics and incidence of infections.

Possible differences in morbidity.

Specific medical conditions (age, BMI, DM, anticoagulants, CVD) versus outcome and morbidity

Outcomes in complicated cases (coumadine use, large prostates, etc)

To define the learning curve

To study differences between lower and higher volume sites

• Inclusion of patients for a one year period

• Study start per site once the first patient is included

• Electronic database will be made available. Once a month an update of the database is provided to the central data collection centre. At the centre a contact person will coordinate the data handling

• The members of the study group will receive on a regular base an update of the data collected

• The data analysis is supported by a Steering committee that are members of the study group

• The Steering committee is composed of 6-8 international members, a chairman and a representative from the sponsor

MANUSCRIPTS PUBLISHED/IN PREPARATION


1) The Clinical Research Office of the Endourological Society (CROES) Global GreenLight™ Laser Study: Outcomes from a contemporary series of 713 patients

Jean JMCH de la Rosette, Mostafa Elhilali, Seiji Naito, Dogan Unal, Hassan Razvi, Evangelos Liatsikos,  Alexander Bachmann, Andrea Tubaro, Gerasimos Alivizatos, Siu-King Mak, Gopal Badlani, Ehab Eltahawy, Carson Wong, Martin Telich Vidal, Alexis Te, Frank CH d’Ancona, Carl Jorgen Arum, Jorge Gutierrez on behalf of the CROES GreenLight Laser Study Group

Published International Journal of Urology 2015 Dec;22(12):1124-30

2) Comparison of GreenLight laser and TURP baseline characteristics and outcomes: lessons learned from the CROES GreenLight Laser Study

Gordon Muir, Jiri Klecka,Daniel J Culkin, Gabriel H Barusso, Jan Kums, Claus R Brunken,Gregg Eure, Carlos Rioja Sanz, Fernando Gomez Sancha, Muharrem M. Yildiz, Jean JMCH de la Rosette, on behalf of the CROES GLS Study Group

In press Minerva Urol Nefrol 2016 Oct 5. [Epub ahead of print]