Transperineal laser ablation as treatment for benign prostatic obstruction: Safety, feasibility and functional outcomes-A pilot study

Background: Standard surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) requires anaesthesia and hospitalization. Transperineal laser ablation (TPLA) is a novel minimally invasive treatment for BPO, which has been performed using local anaesthetics and conscious sedation.Objectives: The aim of this study is to assess safety, feasibility and functional outcomes of TPLA for the treatment of LUTS in men fit also for standard surgery.Methods: This prospective, multicentre, interventional pilot study included 20 patients. Eligible patients were men >= 40 years of age, with urodynamically proven bladder outlet obstruction, a peak urinary flow of 5-15 mL/s and a prostate volume of 30-120 cc. All subjects underwent Soractelite (TM) TPLA using the Echolaser (R) X4 system. Two to four fibres were placed in the prostate, whereafter laser light induced coagulative necrosis. Twelve months of follow-up included uroflowmetry, an ultrasound of the prostate and PROMs (IPSS and IIEF).Results: Twenty patients were treated with TPLA using local anaesthetics and optional sedation. Sixteen patients were treated in an outpatient setting, using only local anaesthetics in 12 of them; four were treated in the operating room, whereof two under general anaesthesia. No device related adverse events occurred, nor did any grade >= 3 adverse events during follow-up. Post-TPLA, 10 men continued spontaneous voiding, and 10 men developed a urinary retention treated by a temporary indwelling catheter for 15.2 +/- 3.5 days. At 12 months, Qmax improved from 9.7 +/- 3.5 to 14.9 +/- 6.0 (p = 0.015), IPSS improved from 21.3 +/- 5.2 to 10.9 +/- 5.5 (p < 0.0001), QoL improved from 4.9 +/- 0.9 to 1.9 +/- 1.1 (p < 0.0001), IIEF-15 total score remained stable and 11/13 patients (85%) preserved antegrade ejaculation.Conclusions: TPLA is a safe and feasible treatment for men with LUTS due to BPO. TPLA can be performed in an outpatient setting under only local anaesthetics. Functional and quality of life outcomes improved significantly at 12 months, and erectile function remained stable.