攝護腺綠光雷射氣化切除術和銩光雷射剜除術之療效比較：
隨機臨床試驗研究，中期報告
許富順、周政緯1、鍾晃昕1、黃國皓ㄉ
台北市立聯合醫院和平院區 泌尿科、新北市立聯合醫院 泌尿科1、台大醫院 泌尿部2
A randomised controlled trial to compare the efficacy of thulium laser enucleation versus Greenlight laser vaporesection of the prostate for the treatment of benign prostatic obstruction: Midterm report
Fu-Shun Hsu, Chen-Wei Chou1, Huang-Hsin Chung1, Kou-How Huang2
Department of Urology, Heping Fuyou Branch, Taipei City Hospital, Taipei, Taiwan;
Department of Urology, New Taipei City Hospital, Taiwan1;
Department of Urology, National Taiwan University Hospital, Taiwan2
Purpose: The aim of this study is to present 6-mont results of a prospective, randomised, single-blinded, single-center, clinical trials to compare outcomes of GreenLight laser 180W vaporesection of the prostate (GLVP) versus thulium laser 200W vapoenucleation (ThuVEP).
Materials and Methods: Between October 2017 and September 2018, a total of 120 patients with symptomatic BPO were assigned under randomization to treat with the GLVP (60 cases) or the ThuVEP (60 cases). Randomization is performed by free randomization software. Only the surgeons knew the operation procedures. Inclusion criteria were maximum flow rate (Qmax) less than 15 ml/second and the International Prostate Symptom Score (IPSS) ≥10. The data of quality-of-life questionnaire (QoL) and transrectal ultrasound of the prostate (TRUS) were obtained preoperatively. TRUS biopsies were performed before surgery in case of suspicious malignancy. Exclusion criteria were prostate cancer, bladder cancer, previous transurethral surgery, and neurogenic bladder. Preoperatively, all patients provided informed consent for surgery. The local institutional review board committee has approved the study as well as the data analysis (106002-F, New Taipei City Hospital). We registered this RCT on clinicaltrials.gov (NCT03318991).
The primary outcome measurement is International Prostate Symptom Score (IPSS) at 1 year. The secondary outcome measurements were maximal uroflowrate (Qmax) and quality-of-life questionnaire (QoL).
Results: The following parameters were assessed preoperatively, at 1-, 3- and 6-months intervals: IPSS, IIEF, Qmax, PVR, QoL, PSA and prostate volume. The hemoglobin difference before and the next day of surgery was documented. The operative time, catheterization time and hospital day were compared in each group.
The peri- and postoperative adverse events (AEs) include blood transfusion, prolonged urinary infection, dysuria, prolonged hematuria, re-catheterization, reoperation, incontinence, urethra stricture and scrotal edema were compared. Those functional results and side effects will be presented.
Conclusion: Since this RCT is still undergoing, we report the midterm results. Both groups lead to a significant symptomatic improvement. There were no significant differences in the IPSS at 6 months, postoperative hemoglobin drop, catheterization time and hospital stay. The AEs were more common in the ThuVEP group but without statistical difference.