The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,000
- Locations
- 4
- Primary Endpoint
- strength of deep muscle fiber I
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •primiparous delivery
- •term delivery
- •single childbirth
- •aged from 18-50yrs
Exclusion Criteria
- •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
Arms & Interventions
device
Patients in this group will be offered pelvic floor muscle rehabilitation program using PHENIX Neuromuscular Stimulation Therapy System device. The participants will start therapy once a week 42 days after delivery, and last 8 weeks.
Intervention: PHENIX Neuromuscular Stimulation Therapy System device (Device)
usual home care without device
Patients in this group will receive usual home care without device.
Intervention: usual home care without device (Other)
Outcomes
Primary Outcomes
strength of deep muscle fiber I
Time Frame: 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
Time Frame: 12 months after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
Time Frame: 12 months after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
Time Frame: 12 months after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
A3 reflex
Time Frame: 12 months after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
dynamic pressure of pelvic floor
Time Frame: 12 months after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
strength of deep muscle fiber I
Time Frame: 42 days after delivery
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber I
Time Frame: 6 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
Time Frame: 42 days after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber II
Time Frame: 6 months after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
Time Frame: 42 days after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
Time Frame: 6 months after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
Time Frame: 42 days after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
Time Frame: 6 months after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
A3 reflex
Time Frame: 42 days after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
A3 reflex
Time Frame: 6 months after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
dynamic pressure of pelvic floor
Time Frame: 42 days after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
dynamic pressure of pelvic floor
Time Frame: 6 months after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
Secondary Outcomes
- 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)
- change from baseline in PFIQ-7 scores(42 days after delivery)
- change from baseline in PFIQ-7 scores(6 months after delivery)
- in subjects sexually active at baseline, assessment of sexual function using PISQ-12(42 days after delivery)
- in subjects sexually active at baseline, assessment of sexual function using PISQ-12(6 months after delivery)