Comparison Between Convective Radiofrequency Water Vapor Thermal Ablation (REZUM) Versus Tamsulosin in Management of Lower Urinary Tract Symptoms in Patients With Benign Prostatic Enlargement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The International Prostate Symptom score (IPSS)
研究概览
简要总结
the investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) with Tamsulosin.
详细描述
So far, data from available studies point towards good clinical outcomes with a short-term risk of self-limiting minor complications. Its application has demonstrated clinical effectiveness and possesses specific benefits that distinguish it among other treatments. It is applicable to outpatient setting, is effective in preserving sexual function and is versatile in its ability to treat a variety of prostate gland morphology.
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
- None
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
- •with prostate volumes of 30- 80 mL,
- •mild to mod LUTS
- •(maximum urinary flow rate [Q max] of <15 mL/s
- •International Prostate Symptom Score [IPSS] of >13)
- •PVR urine < 250 ml
排除标准
- •prostate cancer,
- •neurogenic bladder
- •urethral stricture,
- •urinary bladder stone
- •previous prostatic surgery
研究组 & 干预措施
Rezum group
47 patient underwent Rezum therapy
干预措施: Rezum (Device)
tamsulosin group
47 patients were given Tamsulosin medical treatment
干预措施: Tamsulosin (Drug)
结局指标
主要结局
The International Prostate Symptom score (IPSS)
时间窗: Time Frame: for each case in both groups the investigator assess IPSS at 3, 6, 12 after procedures through study completion, an average of 1 year
Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic
The Maximum Urinary flow rate (Qmax)
时间窗: Time Frame: for each case in both groups the investigator assess Qmax at 3, 6, 12 months after procedures through study completion, an average of 1year
Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 6, 12 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal
The Quality of Life (QoL)
时间窗: [Time Frame: for each case in both groups the investigator assess QoL at 3, 6, 12 months after procedures through study completion, an average of 1 year
Measurement of The Quality of Life (QoL) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy
The Prostate size
时间窗: Time Frame: for each case in both groups the investigator assess prostate size at 3, 6, 12 months after procedures through study completion, an average of 1 year.
the prostate size was measured by grams by Trans-rectal ultra sound
次要结局
- Incidence of complications(through 1 year)
研究者
khaled Abdelsattar Gad Ibrahim
consultatnt doctor
Armed Forces College of Medicine, Cairo, Egypt