Single Center Comparative Trial of Trans-Perineal Laser Ablation Vs Water Vapor Ablation

Treatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI). The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W.

The treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor. Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum). Water vapor emission for 9-second intervals with a maximum of 9 applications per patient. Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment.