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Clinical Trials/NCT01926314
NCT01926314
Unknown
Not Applicable

The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.

Peking Union Medical College Hospital4 sites in 1 country1,000 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primiparous Women With Singleton Baby at Term
Sponsor
Peking Union Medical College Hospital
Enrollment
1000
Locations
4
Primary Endpoint
strength of deep muscle fiber I
Last Updated
12 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2017
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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.

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)

Study Sites (4)

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