The Design and Rationale of a Multicentre Randomised Controlled Trial Comparing Transperineal Percutaneous Laser Ablation With Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia
机构：[1]Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,[2]Shanghai Institute of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,[3]Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China,[4]Department of Urology, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,[5]Hongqiao International Institute of Medicine, Shanghai Tong Ren Hospital, Shanghai, China
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.</p> <br></p> 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.</p> <br></p> 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.</p> <br></p>
基金：
BH received Shanghai Key Discipline of Medical Imaging
Fund (No. 2017ZZ02005) and Shanghai Key Discipline of
Clinical Imaging Fund (No. shslczdzk03203), and financed the
study, including advertising and general publicity expense, the
laboratorial analyses and consumables of participants.
第一作者机构：[1]Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,[2]Shanghai Institute of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,
共同第一作者：
通讯作者：
通讯机构：[1]Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,[2]Shanghai Institute of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated 6th People’s Hospital, Shanghai, China,
推荐引用方式(GB/T 7714)：
Zhang Wei,Zhang Weituo,Guo Qian,et al.The Design and Rationale of a Multicentre Randomised Controlled Trial Comparing Transperineal Percutaneous Laser Ablation With Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia[J].FRONTIERS IN SURGERY.2021,8:doi:10.3389/fsurg.2021.755957.
APA：
Zhang, Wei,Zhang, Weituo,Guo, Qian,Chen, Lei,Meng, Zheying...&Qian, Biyun.(2021).The Design and Rationale of a Multicentre Randomised Controlled Trial Comparing Transperineal Percutaneous Laser Ablation With Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia.FRONTIERS IN SURGERY,8,
MLA：
Zhang, Wei,et al."The Design and Rationale of a Multicentre Randomised Controlled Trial Comparing Transperineal Percutaneous Laser Ablation With Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia".FRONTIERS IN SURGERY 8.(2021)
