Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates.
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men .
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH .
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP
详细描述
Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men.
Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased. BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH.
Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26%.
Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP.
An increasing number of endoscopic techniques have been attempted to overcome these complications. One of the technical modifications of TURP is the bipolar transurethral resection of the prostate (B-TURP) which enables urologists to use normal saline solution as an irrigation fluid to overcome the risk of TUR syndrome occurrence and requires less energy.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •all patients with symptomatizing BPH who have a prostate volume > 60 gm and indicated for surgical treatment.
排除标准
- •patients with small fibrotic prostates, high PSA (not co-inciding with BPH), neurogenic bladder.
研究组 & 干预措施
Bipolar enucleation
Bipolar enucleation of the prostate larger than 60 gm
干预措施: Bipolar Bowa device (Device)
Bipolar TURP
Bipolar transurethral resection of the prostate larger than 60 gm
干预措施: Bipolar Bowa device (Device)
结局指标
主要结局
Assessing and comparing the safety, the surgical efficacy and peri-operative morbidity of bipolar enucleation of the prostate and bipolar transurethral resection of the prostate for the treatment of patients with symptomatizing prostates.
时间窗: one year
Preoperative evaluation will include detailed medical history, thorough clinical examination, international prostate symptom score (IPSS), digital rectal examination (DRE), prostate specific antigen \[Prostatic specific antigen (free/total)\], maximum flow rate (Qmax), and pelvi-abdominal ultrasound to assess prostate size and post-voiding residual urinary volume (PVR). Intraoperative evaluation will include operative time, irrigating fluid volume, the volume of removed prostate tissue, and intraoperative complications. Postoperative evaluation will include the mean haemoglobin difference, hematocrit level, catheterization period, hospital stay, medications, analgesics, and follow up maximum flow rate (Qmax).
次要结局
未报告次要终点
研究者
Mohamed Abdelgawad Rokba
Assistant lecturer, Urology department, Faculty of Medicine, Menoufia University
Menoufia University