Clinical trial NCT01926314: The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction
Official title: The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primiparous Women With Singleton Baby at Term
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* asthma
* long-term abdominal pressure(chronic cough\>1 month,chronic constipation)
* diabetes
* sciatica
* history of pelvic operation

Primary outcomes:
measure: strength of deep muscle fiber I
timeFrame: 42 days after delivery
measure: strength of deep muscle fiber I
timeFrame: 6 months after delivery
measure: strength of deep muscle fiber I
timeFrame: 12 months after delivery
measure: strength of deep muscle fiber II
timeFrame: 42 days after delivery
measure: strength of deep muscle fiber II
timeFrame: 6 months after delivery
measure: strength of deep muscle fiber II
timeFrame: 12 months after delivery
measure: muscular fatigue level
timeFrame: 42 days after delivery
measure: muscular fatigue level
timeFrame: 6 months after delivery
measure: muscular fatigue level
timeFrame: 12 months after delivery
measure: myoelectric potential
timeFrame: 42 days after delivery
measure: myoelectric potential
timeFrame: 6 months after delivery
measure: myoelectric potential
timeFrame: 12 months after delivery
measure: A3 reflex
timeFrame: 42 days after delivery
measure: A3 reflex
timeFrame: 6 months after delivery
measure: A3 reflex
timeFrame: 12 months after delivery
measure: dynamic pressure of pelvic floor
timeFrame: 42 days after delivery
measure: dynamic pressure of pelvic floor
timeFrame: 6 months after delivery
measure: dynamic pressure of pelvic floor
timeFrame: 12 months after delivery
Secondary outcomes:
measure: change from baseline in PFIQ-7 scores
timeFrame: 42 days after delivery
measure: change from baseline in PFIQ-7 scores
timeFrame: 6 months after delivery
measure: change from baseline in PFIQ-7 scores
timeFrame: 12 months after delivery
measure: in subjects sexually active at baseline, assessment of sexual function using PISQ-12
timeFrame: 42 days after delivery
measure: in subjects sexually active at baseline, assessment of sexual function using PISQ-12
timeFrame: 6 months after delivery
measure: in subjects sexually active at baseline, assessment of sexual function using PISQ-12
timeFrame: 12 months after delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Foshan
country: China
facility: Foshan maternal and child health hospital
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou medical college
state: Guangdong
city: Wuxi
country: China
facility: Wuxi Maternal and Child Health Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: