NCT04386941

Greenlight Vaporization vs Xpeeda Vaporesection

Completed NA Last updated 10 April 2025

What this trial tests

NA trial testing Xpeeda Fibre Laser Vaporesection of the Prostate in Benign Prostatic Hyperplasia in 97 participants. Completed in 31 July 2024.

Timeline

31 July 2019

Primary endpoint
10 July 2022

31 July 2024

Quick facts

Lead sponsor	Thunder Bay Regional Health Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	97
Start date	31 July 2019
Primary completion	10 July 2022
Estimated completion	31 July 2024
Sites	1 location across Canada

Drugs / interventions tested

• Xpeeda Fibre Laser Vaporesection of the Prostate
• Greenlight XPS Vaporization of the Prostate

Conditions studied

• Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
• Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →

Sponsor

Thunder Bay Regional Health Research Institute

Who can join

50 and older, male only, with Benign Prostatic Hyperplasia or Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is a common problem, which impact patients' quality of life. It may lead to serious outcomes, including urinary tract infection, hematuria, bladder stones, urinary retention, hydronephrosis, and rarely renal insufficiency.

Introduction of the Holmium laser enucleation of the prostate (HoLEP) represented a turning point in minimally invasive laser therapy for BPH as it achieves size-independent prostatic cavities similar to simple open prostatectomy with significantly lower perioperative morbidity.

Recently, Holmium Xpeeda side firing fibre was introduced and it stands apart from other available technologies as a combination of power and efficiency, which minimizes vaporization time. This technology seems to revolutionize utilization of the Holmium power and delivering more energy directly to the tissue, due to its capability of being in contact with the tissue.

To date, no outcomes of the new Xpeeda laser fiber have been reported in the literature, which is striving for trials comparing XPS 180W with other competitors such as Holmium vaporesection with the new fiber Xpeeda. Therefore, this study is planned to compare both procedures in improving bothersome LUTS secondary to BPH, and to evaluate safety and cost effectiveness.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Holmium Laser Xpeeda Vaporization <i>vs</i> GreenLight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: 1-Year Results from a Randomized Controlled Clinical Study.
   Elmansy H, Zakaria AS, Hodhod A, Shabana W, et al · · 2023 · cited 2× · PMID 37029802 · DOI 10.1089/end.2022.0727