Zhang Wei, Zhang Weituo, Guo Qian, Chen Lei, Meng Zheying, Xu Yanjun, Cao Nailong, Hu Bing, Qian Biyun
Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People's Hospital, Shanghai, China.
Shanghai Institute of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People's Hospital, Shanghai, China.
Front Surg. 2021 Oct 18;8:755957. doi: 10.3389/fsurg.2021.755957. eCollection 2021.
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. 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. 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. The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier [ChiCTR1900022739].
经尿道前列腺切除术（TURP）被视为老年男性良性前列腺增生（BPH）治疗的“金标准”。然而，约15%接受TURP的患者有术中及术后并发症，如出血、尿失禁和尿道狭窄。经会阴经皮激光消融术（TPLA）是一种在超声成像引导下将光纤直接置入前列腺的方法，经会阴经皮途径在尿道和直肠远端进行，以保护这些结构并减少尿道或术后感染。最近已有几项关于TPLA治疗BPH的研究报道；然而，仍缺乏评估其疗效、安全性及长期随访的高质量随机对照试验（RCT）。本研究是一项多中心、开放标签的RCT，旨在评估TPLA与TURP治疗BPH的疗效和安全性。我们假设TPLA在3个月时国际前列腺症状评分（IPSS）相对于基线的变化方面疗效不劣于TURP，且术后并发症发生率更低。114例BPH患者将在19个地点招募，并以1:1随机分配至TPLA或TURP组。术后将在1、3、6、12和24个月对患者进行随访。该研究将是中国、意大利、瑞士和波兰16个参与中心的首个多中心临床试验，样本量相对较大，为114例。通过全面比较TPLA与TURP在BPH患者中的安全性和疗效，特别是在下尿路症状（LUTS）改善和并发症发生率方面，该研究将有助于阐明TPLA的临床价值，并为BPH患者提供一种有益的替代治疗方法。该研究已在中国临床试验注册中心（http://www.chictr.org.cn）注册，标识符为[ChiCTR1900022739]。
