Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Superiority of suprapubic catheter after EERPE
研究概览
简要总结
The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.
详细描述
Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate,
- •Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
- •Be willing/able to adhere to follow up visits
排除标准
- •Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
- •Contraindications for anticholinergic drugs
- •Waist measurement > 100 cm
- •No written informed consent
- •Age < 18 years
- •Subjects with known narrow-angle glaucoma
研究组 & 干预措施
transurethral catheter after EERPE/ RALP
Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
干预措施: transurethral catheter after EERPE/ RALP (Procedure)
transurethral catheter after EERPE/ RALP
Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
干预措施: suprapubic catheter after EERPE /RALP (Procedure)
suprapubic catheter after EERPE /RALP
Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
干预措施: transurethral catheter after EERPE/ RALP (Procedure)
suprapubic catheter after EERPE /RALP
Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
干预措施: suprapubic catheter after EERPE /RALP (Procedure)
结局指标
主要结局
Superiority of suprapubic catheter after EERPE
时间窗: 2nd postoperative day
Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort
次要结局
- Comparison of QoL in both arms measured by visual analogue (pain) scale(1st and 3rd until 5th postoperative day)