Laser Outcomes Associated With HoLEP Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
研究概览
简要总结
The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate.
详细描述
There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2J 50Hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as > 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as >10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates
排除标准
- •Prostates measurements over 200g
- •Patients who lack decisional capacity
- •Patients who are non-english speakers
研究组 & 干预措施
2J 40hz Laser Energy
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz
干预措施: HoLEP (Procedure)
2J 50hz Laser Energy
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz
干预措施: HoLEP (Procedure)
2J 60hz Laser Energy
Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz
干预措施: HoLEP (Procedure)
结局指标
主要结局
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
时间窗: 2 years
Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.
次要结局
未报告次要终点
研究者
Amy Krambeck
Urologic Surgeon
Northwestern University