Safety And Efficacy Of Transurethral Focal Laser Ablation of Prostatic Adenoma In Comparison With Transurethral Prostatectomy For Management Of Benign Prostatic Adenoma Comparative Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum urinary flow rate (Qmax) at 12 months
研究概览
简要总结
Introduction and objectives: Laser prostatectomy has become an increasingly popular and effective alternative to transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH).-. This study focuses on assessing the safety, efficacy, and postoperative complications of Transurethral Focal Laser Ablation of Prostatic Adenoma (TU-FLAP) versus M-TURP in managing BPH, with a 12-month monitoring.
Patients and Methods: 60 BPH cases meeting the inclusion criteria have randomly been assigned into 2 equal groups to undergo either TU-FLAP or M-TURP. Outcomes have been assessed using IPSS, QoL, Qmax, operative time, catheterization ,duration of hospital stay, PVR, PSA, and residual prostate volume. Safety was evaluated based on perioperative and postoperative complications.
详细描述
INTRODUCTION Benign prostatic hyperplasia is a frequent condition between aging men, often leading to lower urinary tract symptoms (LUTS) that significantly impair quality of life. TURP was long considered the gold standard surgical intervention for prostates ranging from 30 to 80 grams [1]. Despite its efficacy, TURP is associated with notable risks, including intraoperative bleeding and the potential for fluid absorption leading to dilutional hyponatremia, commonly referred to as TUR syndrome. These risks are particularly pronounced in patients with larger prostates or those on anticoagulant therapy. Additionally, TURP requires considerable surgical expertise and is associated with a steep learning curve [2].
Transperineal focal laser ablation (TPLA) has emerged as a novel approach, targeting obstructive transitional zone tissue while sparing adjacent structures. This technique achieves debulking by inducing strategic coagulative necrosis, which is subsequently reabsorbed by the body, resulting in reduced prostate volume with minimal impact on urinary continence and sexual function [3]. Similarly, Rezūm therapy utilizes convective water vapor energy to ablate prostatic tissue. It is an office-based procedure that requires no general anesthesia and has demonstrated durable improvement in LUTS while preserving sexual function [4]. Despite these advancements, both TPLA and Rezūm are constrained by limited availability and relatively narrow indications. In this context, TU-FLAP represents a new approach. Unlike existing laser therapies, TU-FLAP is designed to ablate obstructive prostatic adenoma via a transurethral route, without disturbing the urethral mucosa or the ejaculatory ducts. This distinction provides a significant advantage in preserving antegrade ejaculation and reducing the risk of urethral trauma-outcomes often compromised in TURP, HoLEP (Holmium laser Enucleation of the prostate), and other enucleative procedures.
To the best of our knowledge, this is the 1st research to evaluate TU-FLAP using diode laser energy under local anesthesia. The technique leverages real-time endoscopic visualization to deliver precise, targeted energy into the prostatic adenoma, while avoiding direct contact with critical structures such as the urethral sphincter.
This randomized controlled trial was designed to compare TU-FLAP with monopolar TURP in terms of operative metrics, postoperative complications, and patient-reported symptom scores over a one year follow-up duration.
Preoperative workup All cases had a standardized preoperative evaluation, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), and quality of life (QoL) assessment. Physical examination included a digital rectal examination (DRE). Additional assessments included uroflowmetry, urinalysis, and urine culture when indicated, as well as measurement of serum prostate-specific antigen (PSA). Pelvic ultrasound was performed to determine post-void residual urine (PVR), and transrectal ultrasound (TRUS) was used to estimate prostate volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with lower urinary tract symptoms (voiding ± storage) refractory to medical treatment with IPSS > 20 (International Prostate Symptom Score) and Qmax < 15 mL/sec
- •Refractory acute urinary retention
- •Hematuria or recurrent urinary tract infections secondary to BPH
- •Renal impairment secondary to prostatic obstruction
排除标准
- •Proven malignancy by biopsy
- •Urethral strictures
- •Urinary bladder stones
- •Previous prostate surgery
- •Urodynamically proven neurogenic bladder
- •Bladder cancer
- •Unfit for anesthesia
结局指标
主要结局
Maximum urinary flow rate (Qmax) at 12 months
时间窗: Baseline and 12 months
Mean change in maximum urinary flow rate (mL/sec) measured by uroflowmetry compared to baseline.
次要结局
- Change in International Prostate Symptom Score (IPSS) from baseline to 12 months(1 year)
- Post-void residual urine volume (PVR) at 12 months(Baseline and 12 months)
- Operative time (minutes)(1 year)
- Residual prostate volume by transrectal ultrasound (TRUS) at 12 months(Baseline and 12 months)
- Number of participants with intraoperative and postoperative complications(ntraoperative and up to 12 months postoperative)
- Length of hospital stay (days)(Postoperative hospital stay)
- Duration of catheterization (days)(Postoperative period until catheter removal)
- Serum prostate-specific antigen (PSA) at 12 months(Baseline and 12 months)
