NCT06839768招募中不适用
The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
Sechenov University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2024年3月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- The rate of SUI
研究概览
简要总结
Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.
Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •LUTS presence, proven by:
- •IPSS questionnaire (Score >20);
- •OR uroflowmetry result (Qmax <10 ml/s);
排除标准
- •Prostate volume > 120 cc
- •Prostate cancer on pathology;
- •Urethral strictures;
- •Bladder calculi;
- •Prior prostate surgery;
- •Neurogenic bladder dysfunction.
研究组 & 干预措施
EEP (26 Ch)
Active Comparator
干预措施: Standard endoscopic enucleation of the prostate (EEP) (Procedure)
MiLEP (22 Ch)
Experimental
干预措施: MiLEP (Procedure)
结局指标
主要结局
The rate of SUI
时间窗: 1 month
次要结局
- Rate of urethral strictures(6-12 months)
- Hospital stay(participants will be followed for the duration of hospital stay, an expected average of 1,5 days)
- Rate of intra- and perioperative adverse events(the day of operation, at 1, 6,12 months post-operative)
- Operative time(participants will be followed for the duration of the intervention, an expected average of 1 hour)
- Blood loss (blood levels of haemoglobin and haematocrit)(1 day before and 1 day after surgery)
- Catheterization time(participants will be followed for the duration of hospital stay, an expected average of 1,5 days)
- Qmax(1 month)
- International Prostate Symptom Score (IPSS)(1 month)
- PVR(1 month)
- International Index of Erectile Function (IIEF-5)(1 month)
研究者
Vladislav Petov
Assosiate Professor, urologist
Sechenov University
研究点 (1)
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