Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study - Results at 6 and 12 Months From a Retrospective Multi-centric Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
研究概览
简要总结
This study investigated the effectiveness and safety of SoracteLite ™- Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic Benign Prostatic Hyperplasia (BPH) at 6 and 12 months follow-up
详细描述
The purpose of this study was to investigate the effectiveness and safety of SoracteLite ™ - Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. Methods: Patients with urinary symptoms secondary to BPH underwent TPLA under local anaesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥ 50 years of age
- •International Prostate Symptoms (IPSS) ≥12
- •Peak urinary flow rate (Qmax): <15 ml
- •Prostate volume: ≥ 30 ml, measured by transrectal ultrasound
- •Post-void residual (PVR): <400 ml
- •Signed informed consent
排除标准
- •MRI signs of malignancy confirmed by biopsy investigation
- •urethral stenosis
- •serious coagulation disorders
- •inadequate compliance
- •ischemic pathology in the previous six months
- •active phase inflammatory pathology
结局指标
主要结局
Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
时间窗: 12 months
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume
次要结局
- Treatment safety measured by complications incidence(30 days)
研究者
Guglielmo Manenti
Principle Investigator
University of Rome Tor Vergata