NCT04648176Unknown不适用
Evaluation of Surgical and Functional Results of the Application of MOSES Technology in the Holmium Laser Prostate Enucleation as a Treatment for Tract Symptoms Lower Urinary Secondary to Benign Prostatic Hyperplasia
Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Hemoglobin
研究概览
简要总结
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.
详细描述
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostatic volume between 70-200cc
- •Acceptance to participate in the study.
排除标准
- •Previous urethra stricture
- •Previous prostate surgery
- •Neurogenic bladder
- •Bladder tumor
- •Neurological disease with repercussion in the lower urinary tract.
- •Severe psychiatric illness
- •Inability of the patient to consent
结局指标
主要结局
Hemoglobin
时间窗: 24 hours after the surgery
Hemoglobin change
次要结局
- Enucleation time(during the surgery)
- Irrigated volume of serum(during the surgery)
- complication rate(one month after the surgery)
- lower urinary tract symptoms(through study completion, an average of 3 years)
- Hemostasis time(during the surgery)
- Morcellating time(during the surgery)
- sexual function(through study completion, an average of 3 years)
- urinary tract infection(one month after the surgery)
- Surgery time(during the surgery)
研究者
研究点 (2)
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