Blue Diode Laser Vaporization for BPH
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
研究概览
简要总结
This is a prospective data collection of subjects using blude diode laser for the treatment of BPH.
详细描述
This is a prospective single-arm study evaluating the outcome of blue diode laser vaporization. The energy from a 450nm blue laser vaporization will be used for the treatment of BPH. The study period for each patient is 1 year. Recruited subjects will then be followed up at 3 months, 6 months and 12 months after operation. Blood tests, urine tests, ultrasound for prostate volume assessment, uroflowmetry and the same set of questionnaires will be performed again during follow-up for assessing the clinical progress. Any adverse event and unplanned admission will also be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥ 50 years
- •Symptomatic BPH
排除标准
- •Additional procedure is needed e.g. cystolithotripsy, orchidectomy etc
- •Known Ca prostate patients
- •Patients with history of TURP
- •Known Urethral stricture / Bladder stone / Hypercontractile bladder
- •Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
- •Contraindicated to undergo TURP (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
研究组 & 干预措施
Blue light laser Arm
450nm center wavelength blue diode 200W laser is employed for the surgical procedure
干预措施: Blue diode laser (Device)
结局指标
主要结局
Urinary symptoms measured by International Prostate Symptom Score (IPSS) score
时间窗: Baseline, 1 month, 3 months, 6 months, 12 month
Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom
Change in urodynamic in uroflowmetry
时间窗: Baseline, 1 month, 3 months, 6 months, 12 month
Change in urodynamic function assessed by uroflowmetry
次要结局
- Transfusion rate(1 month)
- Patient quality of life(Baseline, 1 month, 3 months, 6 months, 12 month)
- Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score(Baseline, 1 month, 3 months, 6 months, 12 month)
- Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score(Baseline, 1 month, 3 months, 6 months, 12 month)
- Prostate Specific Antigen (PSA) change(Baseline, 1 month, 3 months, 6 months, 12 month)
- Operation Time(Intra-operation)
- Need of post operative irrigation(Peri-operative period)
- Catheter time(1 month, 3 month, 6 month, 12 month)
- Hospital stay(Peri-operative period)
- Verbal dysuria score(First day after catether removal)
- Incidence of unplanned clinic okr hospital attendance(90 days since completion of surgery)
- Adverse events (AE) and serious adverse events (SAE) related to the treatment(Baseline, 1 month, 3 months, 6 months, 12 month)
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong