Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Maximal detrusor pressure
研究概览
简要总结
Holmium laser prostatectomy will enhance voiding function.
Holmium laser prostatectomy will enhance sleep quality.
Holmium laser prostatectomy will enhance renal function.
Holmium laser prostatectomy will enhance erectile function.
Holmium laser prostatectomy will enhance the health-related quality of life.
详细描述
Check urodynamic parameters for voiding function evaluation Check low urinary tract symptoms (IPSS: international prostate symptom score) for voiding function evaluation Check Pittsburgh Sleep Quality Index for sleep quality evaluation Check estimated glomerular filtration rate and urine protein/creatinine ratio for renal function evaluation Check International Index of Erectile Function score (IIEF-5) for erectile function evaluation Check nocturnal penile tumescence parameters for erectile function evaluation Check 36-Item Short- Form Health Survey (SF-36) for evaluation of the health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate size over 30 cc by transrectal ultrasonography
- •prostate-specific antigen level less than 10 ng/ml
- •International prostate symptom score more than 7
- •At least one of followings: Bladder outlet obstruction index > 40, maximal flow rate < 10 cc/sec, postvoid residual urine >100cc or schäfer grade II or more
排除标准
- •Patients who do not want surgery
- •Evidence of prostate cancer or bladder cancer during evaluation or treatment
- •All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
- •Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
- •History of pelvic radiation therapy
- •Poorly controlled diabetes mellitus or hypertension
结局指标
主要结局
Maximal detrusor pressure
时间窗: 3 months
This parameter can be obtained from urodynamic study.
Bladder outlet obstruction index
时间窗: 3 months
This parameter can be obtained from urodynamic study.
Maximal flow rate
时间窗: 3 months
This parameter can be obtained from urodynamic study.
schäfer grade
时间窗: 3 months
This parameter can be obtained from urodynamic study.
Compliance
时间窗: 3 months
This parameter can be obtained from urodynamic study.
次要结局
- Compliance(12 months)
- Maximal flow rate(12 months)
- Maximal detrusor pressure(12 months)
- Bladder outlet obstruction index(12 months)
- schäfer grade(12 months)
研究者
Seung-Ju Lee
Senior researcher
The Catholic University of Korea