Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Patient satisfaction score
研究概览
简要总结
In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction.
It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial.
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
- •Male ≥ 18 years old
- •With an indwelling urinary catheter placed after any of the following procedures:
- •A uro-endoscopic surgery from the list below:
- •Endoscopic prostate resection (or transurethral prostate resection).
- •Laser prostate enucleation
- •Prostate thermotherapy by radiofrequency
- •A high-intensity focused ultrasound treatment for prostate cancer
- •Cervico-prostatic incision or internal urethrotomy
- •Endoscopic/Transurethral Resection of Bladder Tumor (TURBT)
- •Surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation)
- •Patient who has given written consent to participate
排除标准
- •Patient who is unable to perform intimate hygiene alone in a standing position
- •Patient with a painful genital lesion
- •Patient with an extended pelvic pathology
- •Need to remove the indwelling urinary catheter at the patient's home instead of hospital
- •Patient under guardianship or curator
- •Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions
研究组 & 干预措施
Passive indwelling urinary catheter removal
The passive indwelling urinary catheter removal takes place due to gravity.
干预措施: Passive indwelling urinary catheter removal (Procedure)
Manual indwelling urinary catheter removal
The manual indwelling urinary catheter removal takes place by manual traction by a nurse.
干预措施: Active indwelling catheter removal by a nurse (Procedure)
结局指标
主要结局
Patient satisfaction score
时间窗: Within one hour after indwelling urinary catheter removal at day 0
Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)
次要结局
- The pain experienced by patients(Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter))
- The anxiety experienced by patients(Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter))
- Patient satisfaction(at Day 2, at Day 15)
- Patient satisfaction(at Day 0, at Day 2, at Day 15)