Randomized Clinical Trial Comparing Transurethral Prostate Resection (TURP) and Echolaser Soractelite-Transperineal Laser Ablation (TPLA ) in Patients With Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)
研究概览
简要总结
THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Lower urinary tract symptoms (IPSS >= 8);
- •Poor efficacy after at least six months of medical therapy or intolerance to medical treatment for BPH;
- •Prostate volume: 40ml-80ml;
- •Ability to give informed consent.
排除标准
- •Previous surgery for benign prostatic hyperplasia;
- •Indwelling bladder catheter or intermittent bladder catheterization;
- •Diagnosis of bladder stones;
- •Recurrent urinary tract infections or intraprostatic abscesses;
- •Severe detrusor hypocontractility or acontractility;
- •Hydronefrosis due to urinary retention;
- •Urethral strictures or diagnosis of neurogenic bladder;
- •Diagnosis of bladder cancer;
- •Diagnosis or clinical suspicion of prostate cancer.
研究组 & 干预措施
TPLA
Patients underwent TPLA tretment
干预措施: ECHOLASER-TPLA (Procedure)
TURP
Patients underwent TURP tretment
干预措施: TURP (Procedure)
结局指标
主要结局
Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)
时间窗: one, three, six, twelve months after treatment
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms
IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE
时间窗: one, three, six, twelve mounth after treatment
次要结局
- Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (MSHQ-EJD)(Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment)
- Changes in Post Void Residual (PVR)(Differences among preoperative status versus 3, 6, 12 months after treatment)
- Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)(Differences among preoperative status versus 6, 12 months after treatment)
- Length of hospital stay(From hospital admission to discharge at three days (up to three days))
- Changes in Sexual Funtion(Differences among preoperative status versus 3, 6, 12 months after treatment)
- Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score(Differences among preoperative status versus 3, 6, 12 months after treatment)
- Change in Pelvic Pain and Urgency/Frequency (PUF) score(Differences among preoperative status versus 3, 6, 12 months after treatment)
- Prostate Specific Antigen (PSA) value(Differences among preoperative status versus 3, 6, 12 months after treatment)
- Postoperative complications(up to 3 months)
- Duration of urinary catheterization(From catheter insertion to catheter removal at seven days (up to seven days))
- Operative time(During the surgical procedure (day 0))
- COMPARE Q-MAX UROFLOW(one, three, six, twelve mounth after treatment)
- COMPARE INPATIENT-TIMING(one, three, six, twelve mounth after treatment)
研究者
Pasquale Ditonno
MD
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari