Background: Transurethral resection of the prostate (TURP) is regarded as the “gold standard” for the treatment of benign prostatic hyperplasia (BPH) in elderly men. However, ~15% of patients who had undergone TURP had intraoperative and postoperative complications, such as bleeding, urinary incontinence and urethral stricture. Transperineal percutaneous laser ablation (TPLA) is a method that places the optical fibre directly into the prostate with the guidance of ultrasound imaging, and the percutaneous transperineal approach is performed distal to the urethra and rectum to protect these structures and reduce urethral or postoperative infection. Several studies on TPLA for BPH treatment have been reported recently; however, high-quality randomised controlled trial (RCT) to evaluate its efficacy, safety, and long-term follow up remain absent.Methods: This study is a multicentre, open-label RCT to assess the efficacy and safety of TPLA vs. TURP to treat BPH. We hypothesise that the TPLA has non-inferior efficacy to TURP in the International Prostate Symptom Score (IPSS) at 3 months changing from the baseline and lower incidence of post-surgery complications. One hundred and fourteen patients with BPH will be recruited at 19 sites and randomly assigned at 1:1 to TPLA or TURP groups. The patients will be followed up at 1, 3, 6, 12, and 24 months after the procedure.Discussion: The study will be the first multicentre clinical trial including 16 participating centres in China, Italy, Switzerland, and Poland with relatively large sample size 114. By comprehensively compare the safety and efficacy of TPLA with TURP in patients with BPH, especially concerning the improvement of lower urinary tract symptoms (LUTS) and complication incidence, the study will help to illustrate the clinical value of TPLA and provide a beneficial alternative treatment for BPH patients.Clinical Trial Registration: The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier [ChiCTR1900022739].

BACKGROUND: Transperineal percutaneous laser ablation (TPLA) has been proved a feasible and minimally invasive treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). However, the comparison with other therapeutic options, in particular transurethral resection of the prostate (TURP), the most widely used and gold standard surgical method for BPH patients, remained absent. METHODS: Totally 51 BPH patients treated between 6/2019 and 12/2021 who had maximum urinary flow rate (Qmax) ≤15 mL/s and international prostate symptom score (IPSS) ≥8 were enrolled and randomly assigned to TURP or TPLA group at the ratio 1:1. TPLA was conducted with Esaote MyLab Twice equipped with flexible optical fiber, and TURP was performed by Olympus UES-40 SurgMaster System under standard procedure. The results were compared at 1, 3, 6 and 12 months after the operation. The efficacy endpoints included IPSS, Qmax, quality of life (QoL), European questionnaire-five dimensions (EQ-5D), residual urine volume (RUV), international index of erectile function-5 (IIEF-5) and ejaculatory dysfunction score. The safety endpoints included the incidence of complications, blood loss, visual analogue score (VAS) of pain, and catheter indwelling time. RESULTS: The IPSS decreased by 14.17±6.13 at 3 months after TPLA, and by 13.19±5.86 after TURP (P=0.706). The complication rate of TPLA and TURP was 16% and 19.23% respectively (P=0.811).TPLA proved less Intraoperative blood loss (6.84±3.1mL,P＜0.001) and better ejaculatory protection within 6 months (P＜0.05). TURP has advantages in catheter indwelling time(P=0.012) and Qmax within 6 months(P＜0.05). CONCLUSIONS: TPLA is comparable to TURP in the symptom relief of BPH patients, and with shorter operation time, less invasiveness and better protection, which may be more suitable for patients intolerant to TURP, or with underlying diseases such as anemia.