Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- failure rate of a limited catheterization duration of 3 hours post- operative
研究概览
简要总结
Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma.
In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with lower urinary tract symptoms (LUTS )
- •IPSS≥ 15 despite medical treatment > 1 month if monotherapy or > 3 months if bitherapie OR acute urinary retention ( RAU ) non-medical after the 1st failure to remove the catheter OR acute prostatitis OR macroscopic haematuria of prostatic origin
- •prostate volume > 30 cc by transrectal ultrasonography ;
- •IPSS Qol ≥ 3 has at inclusion ;
- •PSA ≤ 4 ng / ml ;
- •if PSA between 4 and 10 then PSA L/T ≥25 % or negative PBP <6 months .
- •Accommodation <50 km;
- •company available for the return at home and monitoring first post- operative night .
- •patient sign the informed consent
- •patient covered by social security or other health insurance
排除标准
- •post- voiding residue > 250 cc by suprapubic ultrasound not older than < 45 days
- •prostate volume > 100 cc by transrectal ultrasound not older than 45 days
- •urological antecedents : o urethral stenosis or cervical disease
- •UTI in progress
- •SAD patient or self-catheterization
- •obstructive hydronephrosis + / - renal failure
- •vesical calculi
- •cancer of the prostate treated or untreated
- •bladder tumor associated
- •Interstitial cystitis ( symptom or biopsy)
- •antecedent of the prostate surgery
- •neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, Diabetic, cauda equina syndrome )
- •criteria related concomitant medications that can not be stopped at least < 48 hours before PVP with GL XPS 180 W
- •contra indication for outpatient care for medical reason
- •contra indication of a product analgesic according to protocol
- •patient inability to understand and sign the informed consent as well as completing the questionnaires
- •ASA Score > 3 .
研究组 & 干预措施
rate of early removal of the catheter
In our study, we propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia for limiting autonomic effects on the bladder and ensure fastest possible recovery of voiding .
干预措施: Catheter (Other)
结局指标
主要结局
failure rate of a limited catheterization duration of 3 hours post- operative
时间窗: at three hours post surgery
• The failure rate of a limited catheterization duration of 3 hours post- operative is defined by a need of recatheterizatrion within 24 hours post- GL with PVP XPS 180W . The catheterization remains indicated in case of macroscopic hematuria RAU or if no natural urination is possible
次要结局
- The duration of recatherization(during 24 hours hospitalisation)
- Total dose of energy(during 24 hours hospitalisation)