NCT01043588已完成不适用
Transurethral Resection of the Prostate With Photo Selective Vaporization of the Prostate Using the High Powered 532nm Laser Obstructive Benign Prostatic Hyperplasia Management: Focus on Efficiency and Cost-effectiveness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Hospital stay
研究概览
简要总结
The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser.
详细描述
The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser. Patients were randomized in two groups after inclusion. Perioperative data were collected, and follow-up was conducted for one month.
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
- 否
入选标准
- •Male, 50 years of age or older.
- •American Society of Anesthesiology (ASA) classification of physical status, class 1-3
- •Signed an informed consent at the beginning of the study.
- •Patients presenting with LUTS associated to benign prostatic enlargement for more than 3 months, needing a surgical management, with at least one of the following situations: disability score ≥3, I-PSS ≥12, or full urinary retention
- •Qmax ≤12ml /s for no drained patients with voided volume> 125 ml.
- •Estimated prostate weight between 25g and 80g
- •Patient free of catheter with PVR ≤ 300cc
- •Patient without renal disorders.
- •No prostate cancer suspicion at clinical examination, including DRE.
- •PSA ≤ 10 ng/ml, with negative prostate biopsies of PSA is between 4 and 10 ng/mL if patient is 75 years or younger or has a life expectancy of more than 10 years.
- •In case of anticoagulation or anti-aggregation therapy, necessary preoperative visit by anaesthesiologist to determine the supply therapy around surgery.
- •In case of current BPH medical management, alpha blockers and herbal medicines should be stopped one week before surgery and 5-alpha-reductase-inhibitors should be stopped one month before surgery.
- •Patient must be affiliated to the French social healthcare or equivalent
排除标准
- •Uncontrolled cardiopulmonary disorder, previously or recently diagnosed by standard methods
- •Assessed sphincter detrusor dyssynergia, or myasthenia, multiple sclerosis, or Parkinson disease.
- •History of pelvic lesions with abdominal sphincter injury.
- •Urinary tract infection without antibiotics.
- •Patient with urinary catheter or suprapubic catheter because of an acute urinary retention linked to an alternative diagnosis or impaired bladder sensation.
- •Subject with neurogenic bladder and/or sphincter abnormalities
- •Subject with confirmed or suspected malignancy of the prostate or the bladder.
- •Previous prostatic surgery.
- •History of bladder stone, major hematuria, urethral stricture, bladder neck stenosis.
- •Patient having a prosthesis in the procedure area
- •Patient with an active anorectal disease
- •Treatment emergency
- •Individual unable to respect timing and visits determined by the protocol.
- •Constitutional hemostasis and coagulation abnormalities not linked to oral medications
- •Any disease or patient condition which can be a contra indication to his enrolment in the study, according to the investigator.
结局指标
主要结局
Hospital stay
时间窗: end of hospitalization
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
时间窗: at one year
次要结局
- Rate of complication needing re-hospitalisation or reintervention(from the surgical procedure until one year follow-up)
- Risk of ignoring a localized prostate cancer needing a curative management.(at one year)
- Total and post-operative costs during follow-up.(from the surgical procedure until one year follow-up)
- Evaluation of side effects during follow-up.(from the surgical procedure until one year follow-up)
- Patient satisfaction(during follow up)
- Evaluation of quality of life(during follow up)
研究者
研究点 (2)
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