The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction

Not Applicable

• Conditions: Primiparous Women With Singleton Baby at Term
• Interventions: Device: PHENIX Neuromuscular Stimulation Therapy System device; Other: usual home care without device

• Registration Number: NCT01926314
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted: 2013-08-17
• Study First Submitted QC: 2013-08-19
• Last Update Submitted: 2013-08-19
• Study First Posted: 2013-08-20
• Last Update Posted: 2013-08-20
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
device	PHENIX Neuromuscular Stimulation Therapy System 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.
usual home care without device	usual home care without device	Patients in this group will receive usual home care without device.

Primary Outcome Measures

Name	Time	Method
strength of deep muscle fiber I	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	12 months after delivery	Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level	12 months after delivery	muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
myoelectric potential	12 months after delivery	myoelectric potential is one of the index of electrophysiology function of pelvic floor.
A3 reflex	12 months after delivery	A3 reflex is one of the index of urinary continence function of pelvic floor.
dynamic pressure of pelvic floor	12 months after delivery	dynamic pressure of pelvic floor is one of the index of urinary continence function.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Wuxi Maternal and Child Health Hospital, Nanjing Medical University; 🇨🇳 Wuxi, Jiangsu, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Foshan maternal and child health hospital; 🇨🇳 Foshan, Guangdong, China

The first affiliated hospital of Guangzhou medical college; 🇨🇳 Guangzhou, Guangdong, China