Database for the Assessment of Efficacy and Safety of BPH Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Changes of free urinary flow rate
研究概览
简要总结
This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).
详细描述
This registry study aims to collect data on efficacy and safety of different treatments of benign prostatic enlargement (BPE) and lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS).
Clinical, patient reported and imaging data that are assessed in clinical routine will be prospectively collected. All patients that are treated for BPE / BPH-LUTS at our institution will be included if they provide written informed consent.
This registry enables us to compare novel treatment option (e.g. prostatic artery embolization; PAE) to established interventions (e.g., TURP, HoLEP, open prostatectomy, ThuLEP, Thulium laser vaporization, TUIP) regarding safety and efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •All patients treated for BPH / LUTS / prostatic obstruction at the urological department of KSSG
- •Patient age ≥ 18 years
- •Informed consent provided
排除标准
- •Cognitive impairment not allowing Informed Consent or adequate data assessment.
结局指标
主要结局
Changes of free urinary flow rate
时间窗: baseline to 1 year
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Changes of post void residual urine
时间窗: baseline to 1 year
Measurement of post void residual urine (mL) by transabdominal ultrasound
Reduction of Lower Urinary Tract Symptoms
时间窗: baseline to 1 year
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
次要结局
- Adverse Events(5 years after intervention)
- Changes of free urinary flow rate(baseline to 5 years)
- Reduction of Lower Urinary Tract Symptoms(baseline to 5 years)
- Changes of post void residual urine(baseline to 5 years)
- Rate of local reinterventions(during 5 year study period)
- Rate of local medical treatment for BPH-LUTS(during 5 year study period)
- Urodynamic changes(during 5 year study period)
- Reduction of Prostate symptoms(baseline to 5 years)
- Assessment of erectile function(5 years after intervention)
- Ejaculatory function(5 years after intervention)
- Change of prostate size(5 years after intervention)
- PSA(5 years after intervention)
研究者
Dominik Abt
Dr. med. Dominik Abt
Cantonal Hospital of St. Gallen