Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Post-operative Urinary Incontinence
研究概览
简要总结
To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older
- •Patients must present to clinic with a diagnosis of benign prostatic hyperplasia
- •Patients must be scheduled to undergo a holmium laser enucleation of the prostate
排除标准
- •Patients with previous surgical management of BPH
- •Patients with prostate biopsy revealing high risk prostate cancer
- •Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
研究组 & 干预措施
Early apical release holmium enucleation of the prostate
Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
干预措施: EAR HoLEP (Procedure)
Classic holmium enucleation of the prostate
Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia
干预措施: Classic HoLEP (Procedure)
结局指标
主要结局
Post-operative Urinary Incontinence
时间窗: Twelve Months Post-operative
to determine if patients who undergo early apical release HoLEP have reduced rates of post-operative urinary incontinence compared to classic HoLEP as measured by patient report of leakage
次要结局
未报告次要终点
研究者
Don Neff, MD, FACS
Associate Professor
University of Kansas Medical Center