Monopolar Versus Bipolar Transurethral Resection of the Prostate in patients with Benign Prostatic Enlargement: A Prospective Randomized Comparative Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Objective (Post voiding residual urine-PVR, and Maximum urine flow rate- Qmax) parameters.
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a common disease in middle aged and elderly men; and one of the most common etiology of lower urinary tract symptoms (LUTS). It may cause urinary urgency, frequency, nocturia, dysuria, and complications such as urinary tract infection, bladder stones, and hydronephrosis that sharply affect the quality of life (QOL). Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased. Therefore, prompt and effective interventions are necessary for treating BPH. It can be treated with pharmacotherapies and with surgery. Usually, surgery is needed to achieve satisfactory outcomes when patient is refractory to medical management.
Monopolar transurethral resection of prostate (M-TURP) is considered the gold standard for the management of bladder outlet obstruction due to BPH. Its newly introduced modification, bipolar TURP (B-TURP), promises to overcome its most prominent shortcomings, namely bleeding and dilutional hyponatremia. Literature is conflicting regarding merits of B-TURP over M-TURP, so we have decided to conduct this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age – >50 years.
- •2.All patients of lower urinary tract symptoms (LUTS) not responding to medical treatment.
- •Prostate size: 30 to 100 grams.
- •IPSS score >7.
排除标准
- •Patients with history of prior TURP, Carcinoma Prostate.
- •BPH with associated conditions (Bladder calculus, bladder diverticula, bladder tumour, urethral stricture).
- •Patients with comorbidities who are unfit for surgery.
- •Neurogenic bladder.
- •Patients who did not give written informed consent.
结局指标
主要结局
1. Objective (Post voiding residual urine-PVR, and Maximum urine flow rate- Qmax) parameters.
时间窗: 1 week, 1 month, 3 month
2. Subjective (IPSS score and quality of life-QoL) parameters.
时间窗: 1 week, 1 month, 3 month
次要结局
- 1. Perioperative parameters (Change in Haemoglobin, Sodium, Potassium; resection time, obturator jerk, TUR syndrome, catheter duration, amount of irrigation fluid used and its duration, hospital stay, failed TWOC- trial of voiding without catheter).(2. Complications, if any (According to the modified clavien grading system).)