Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients: a Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- clean intermittent self-catheterization
研究概览
简要总结
The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer.
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
- 27 Years 至 81 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.
排除标准
- •All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.
研究组 & 干预措施
Bladder training group
The patients of this group were submitted to passive vesical gymnastic during the second and third postoperative days, throughout the closure of the catheter for 3 h and open it for 15 min all day long.
干预措施: bladder training (Device)
No bladder training group
The patients of this group were not submitted to passive vesical gymnastic during the second and third postoperative days
干预措施: No bladder training (Procedure)
结局指标
主要结局
clean intermittent self-catheterization
时间窗: three days
necessity and duration of clean intermittent self-catheterization after three days
次要结局
未报告次要终点
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart