Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Measurement of The International Prostate Symptom score (IPSS) in both groups
研究概览
简要总结
We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.
详细描述
For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP.
Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size <80 gm and for those wishing to maintain antegrade ejaculation. While they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.
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
- •Patients aged 50-80 years
- •prostate volumes of 50-120 ml
- •sexually active
- •severe LUTS
- •[Q max] of <10 ml/s
- •[IPSS] of >20)
- •failed medical treatment with alpha blockers
排除标准
- •prostate cancer
- •Neurogenic bladder
- •urethral stricture
- •urinary bladder stone
- •previous prostatic surgery.
结局指标
主要结局
Measurement of The International Prostate Symptom score (IPSS) in both groups
时间窗: for each case in both groups the investigator assess IPSS at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 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
Measurement of The International Index of Erectile Function (IIEF) in both groups
时间窗: for each case in both groups the investigator assess IIEF at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
The operative time of both groups
时间窗: for each case in both groups the investigator assess the time of operation from induction of anaesthesiatill the end of the operation through study completion, an average of 2 years
the operative time was measured by minutes in both groups.
Post operative hospital stay time in both groups
时间窗: for each case in both groups the investigator assess the hospital time from the day of admission of the patient in hospital to do intervention till discharge from hospital through study completion, an average of 2 years
the Post operative hospital stay time was measured by hours in both groups.
Measurement of Post operative residual urine (PVR)
时间窗: for each case in both groups the investigator assess prostate size at 6, 12 and 24 months after procedures through study completion, an average of 2 years
PVR was measured by ml by pelvi abdominal ultra sound in both groups. Normal ranges are below 150 ml of urine.
Measurement of The Quality of Life (QoL) in both groups
时间窗: for each case in both groups the investigator assess QoLat 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy
Measurement of The Maximum Urinary flow rate (Qmax) in both groups
时间窗: for each case in both groups the investigator assess Qmax at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 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
Concentration of The Prostatic specific antigen (PSA) in both groups
时间窗: for each case in both groups the investigator measures PSA at 6, 12, and 24 months after procedures through study completion, an average of 2 years
After 6, 12, and 24 months of operation, the procedure is performed. PSA is measured by ng/ml PSA levels of 4.0 ng/mL and lower were considered
Measurement of The Prostate size
时间窗: for each case in both groups the investigator assess prostate size at 24 months after procedures through study completion, an average of 2 years
the prostate size was measured by grams by Trans-rectal ultra sound
Incidence of The catheter duration post operative in both groups
时间窗: for each case in both groups the investigator assess the catheter duration from the end of the operation till removal through study completion, an average of 2 years
The catheter duration was measured by days in both groups.
次要结局
- Incidence of complications(through two years)