Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- maximum urine flow rate (Qmax)
研究概览
简要总结
To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.
详细描述
Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population.
The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
Lower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial.
LUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom.
Multiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate volume less than 80 ml
- •high IPSS more than 19 affecting quality of life
- •recurrent urinary retention with failure of medical treatment
- •recurrent urinary tract infection
- •affection of upper urinary tract
- •refractory hematuria
- •bladder stones
- •bladder diverticula
排除标准
- •patients with neurogenic bladder
- •patients with previous prostate or urethral surgery
- •associated urethral stricture
- •prostate cancer diagnosed by TRUS biopsy
- •prostate volume more than 80 ml
结局指标
主要结局
maximum urine flow rate (Qmax)
时间窗: 1 year
assessing the improvement of Qmax
the international prostate symptom score (IPSS)
时间窗: 1 year
assessing the improvement of IPSS
次要结局
- operative time(immediately postoperative)
- postoperative catheterization time(4 days postoperative)
- resected volume(immediately postoperative)
- postoperative drop in hemaoglobin level(1 day postoperative)
- postvoiding residual urine volume(1 year)
- postoperative drop in sodium level(1 day postoperative)
- duration of hospital stay(3 days postoperative)
- ultrasound assessed prostate volume(1 year)