NCT03589196Unknown不适用
Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate For Management Of Benign Prostatic Enlargement: An Objective Evaluation Through a Prospective Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
研究概览
简要总结
To Evaluate and compare the outcome and coast of ejaculation sparing management of BPH using 3 different techniques: PVP, PKVP and TURP. Ejaculation sparing TURP group is considered the standard control group. Evaluation will be carried out through a prospective randomized powered trial
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age >50 years
- •Prostate volume (measured by TRUS): 30-80 gm
- •International prostate symptom score (IPSS )>15 and quality of life score (QOL)<
- •Maximum flow rate of uroflometry <10 ml/second
- •Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation.
- •Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO.
排除标准
- •Bleeding disorders and patients on anticoagulant treatment
- •Histologically proved cancer prostate
- •Neurogenic voiding dysfunction
- •Lower urinary tract malignancy
- •Preoperative ejaculation or sexual dysfunction
- •Presence of stricture urethra
- •Unfit for spinal anathesia -
研究组 & 干预措施
Photoselective Vaporization
Active Comparator
干预措施: Ejaculation Preserving Photoselective Vaporization (Procedure)
Plasma Kinetic Vaporization
Active Comparator
干预措施: Ejaculation Preserving Plasma Kinetic Vaporization (Procedure)
Transurethral Resection Of The Prostate
Active Comparator
干预措施: Ejaculation Preserving Transurethral Resection Of The Prostate (Procedure)
结局指标
主要结局
estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
时间窗: 1 years
assessed by Male Sexual Health Questionnaire (MSHQ)
次要结局
- change in flow rate(1 years)
- postoperative complication(1 year)
- change in patients' symptoms.(1 year)
研究者
研究点 (1)
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