Soractelite(Tm) Transperineal Laser Ablation for Benign Prostatic Hyperplasia With Bladder Outlet Obstruction

INTRODUCTION

The Echolaser system (ELS - Elesta SpA. 50041, Calenzano (FI), Italy ), which consists of Echolaser X4 plus Echolaser Smart Interface is a new device for minimal invasive procedures. The system induces tissue coagulation thru a continuous 1064 nm laser wave. Light tissue interaction is reliable, reproducible, and safe. The laser fiber tip induces necrosis near the tip and coagulative effects deeper in tissues thru heat ablation. The body cleans up treated tissue over time. Much experience is gained with laser application in different organs. A preliminary study conducted in Europe by the investigators showed promising results (1)

About 4 out 5 men experience bothersome alterations in their voiding pattern. This pervasive condition usually begins in the 5th decade of life. These patients usually express complaints of Urinary urgency, frequency and nocturia as the sensation of incomplete voiding and decrease in the force of stream leading to stranguria. Lower Urinary Tract Symptoms (LUTS) is the common term that represents constellation of these symptoms, most triggered by prostate enlargement, commonly referred as Benign Prostatic Hyperplasia (BPH). Today management of BPH may call for medications such as alpha-blockers, 5 alpha reductase inhibitors, phosphodiesterase inhibitors or combination of them. In addition, there surgical approaches to improve BPH, they are based on cytodestruction or excision of prostate tissue. These surgical approaches range from office based minimally invasive to hospital based robotically conducted. Office based minimally invasive approaches are favored by patients given their low-risk nature, safety profile and avoidance of general or spinal anesthesia. Furthermore, minimally invasive approaches aim to preserve the bladder neck, this avoids alterations in sexual function such as retrograde ejaculation. Excision or resection of the bladder neck is a major step of definitive invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open. Bladder neck resection portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation. This is a tradeoff that evokes hesitation in many men to resolve their BPH. Minimally invasive procedures have emerged aiming to relieve BPH without sacrificing the bladder neck. They carry two major advantages: preservation of ejaculation and absence of major anesthesia requirements, thus amenable to office setting execution. The latter provides significant saving to the health system and decreases post-operatory risks of adverse events in a not insignificant manner. The fundamental question raised to minimal invasive procedures relates to degree of subjective and objective response, durability of BPH relief, ability to wean off from medications and impact on quality of life, from a two domain - urinary and sexual perspective.

The ELS is a novel disruptive approach that allows a transperineal approach and provides for a safe and simultaneous multiple laser fiber energy delivery that translated in expediency and decreased procedure times. ELS has been safely conducted in men with BPH in the ambulatory setting, as a procedure called SoracteLiteTM transperineal laser ablation (TPLA), performed in men with LUTS due to BPH that were suboptimal candidates for surgery, they exhibited good tolerability with minimal adverse event profiles. To the investigators knowledge, there is no data or evaluation of its safety profile if/when conducted in an office setting under local anesthesia. Therefore, in this study the investigators aim to assess efficacy, tolerability, response and safety profile of SoracteLite™ TPLA conducted in men with LUTS due to BPH in the office setting.

Objective: The primary objective of this study is to assess efficacy, tolerability, short term response and safety profile of SoracteLite™ TPLA for LUTS due to BPH in healthy men. The secondary objectives are to evaluate quality of life changes in erectile and sexual function as the well as imaging volumetric changes in prostate size.