28Fr Versus 22Fr HoLEP, a Randomized Controlled Trial Indiana University School of Medicine, Department of Urology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
研究概览
简要总结
The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
详细描述
This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years old Undergoing HoLEP for benign prostatic enlargement Eligible for same day catheter removal
排除标准
- •Age < 18 years old
- •Existing stress or urge urinary incontinence
- •Planned overnight admission or overnight catheterization
研究组 & 干预措施
HoLEP surgery with 22Fr
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
干预措施: 22 French sized rigid sheath (Device)
HoLEP surgery with 28Fr
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
干预措施: 28 French sized rigid sheath (Device)
结局指标
主要结局
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
时间窗: M-ISI survey completed at 1,4,12 weeks
Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey.
次要结局
未报告次要终点
研究者
Marcelino Rivera
Assistant Professor of Urology
Indiana University