The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- strength of deep muscle fiber I
研究概览
简要总结
Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training with the device "PHENIX Neuromuscular Stimulation Therapy Systems" on the recovery of pelvic floor function for primiparous women.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primiparous delivery
- •term delivery
- •single childbirth
- •aged from 18-50yrs
排除标准
- •urinary incontinence before pregnancy
- •fecal incontinence before pregnancy
- •organ prolapse before pregnancy
- •history of childbirth or induced labor with pregnancy more than 28 weeks
- •multiparity
- •newborn weight less than 2500 grams or more than 4000 grams
- •precipitate labor
- •complication of pregnancy
- •long-term abdominal pressure(chronic cough>1 month,chronic constipation)
- •history of pelvic operation
结局指标
主要结局
strength of deep muscle fiber I
时间窗: 12 months after delivery
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber II
时间窗: 12 months after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
时间窗: 12 months after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
时间窗: 12 months after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
A3 reflex
时间窗: 12 months after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
dynamic pressure of pelvic floor
时间窗: 12 months after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
次要结局
- change from baseline in PFIQ-7 scores(12 months after delivery)
- in subjects sexually active at baseline, assessment of sexual function using PISQ-12(12 months after delivery)