Beijing Key Laboratory of Female Pelvic Floor Disorders of Peking University People's Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- the rate of urinary retention
研究概览
简要总结
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 126 patients who undergo the pelvic reconstructive surgery. 63 patients in the intervention group accept 10 times of the transcutaneous electrical nerve stimulation.
详细描述
All the patients have severe pelvic organ prolapse and undergo the pelvic reconstructive surgery. Investigators evaluate all patients' lower urinary tract symptoms, quality of life score, overactive bladder questionnaire, maximal rate and residual urine volume, at 1, 3, 6 and 12 months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •severe pelvic organ prolapse(POP-Q:3/4 stage)
- •accept pelvic reconstructive surgery
排除标准
- •Dominant stress urinary incontinence
- •Serious medical problems
- •mental disease
- •infectious disease
研究组 & 干预措施
The intervention group
the transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
干预措施: PHENIX4-8-8 PLUS (Device)
The observational group
routine nursing
结局指标
主要结局
the rate of urinary retention
时间窗: three days after surgery
urinary residual volume
次要结局
- the rate of urinary incontinence(three days; seven days; one month; three months; six months after surgery)