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

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

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 Overview

• Status: Unknown
• Conditions: Primiparous Women With Singleton Baby at Term
• Intervention / Treatment: Device: PHENIX Neuromuscular Stimulation Therapy System device; Other: usual home care without device

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Lan Zhu; Phone Number: 86-10-69156238; Email: zhu_julie@sina.com
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Foshan Maternal and Child Health Hospital
      • Contact: Yuling Wang; Phone Number: 86-13049161630; Email: wujun701121@126.com
      • Principal Investigator: Yuling Wang
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical College
      • Contact: Xiaowei Zhang; Phone Number: 86-13609086710; Email: xwzhang81341235@163.com
  • Jiangsu
    • Wuxi, Jiangsu, China, 214002
      • Recruiting
      • Wuxi Maternal and Child Health Hospital, Nanjing Medical University
      • Contact: Jian Gong; Email: gongjianwx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: PHENIX Neuromuscular Stimulation Therapy System device
Active Comparator: usual home care without device; Patients in this group will receive usual home care without device.	Other: usual home care without device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
strength of deep muscle fiber I	Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.	42 days after delivery
strength of deep muscle fiber I	Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.	6 months after delivery
strength of deep muscle fiber I	Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.	12 months after delivery
strength of deep muscle fiber II	Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.	42 days after delivery
strength of deep muscle fiber II	Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.	6 months after delivery
strength of deep muscle fiber II	Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.	12 months after delivery
muscular fatigue level	muscular fatigue level is one of the index of electrophysiology function of pelvic floor.	42 days after delivery
muscular fatigue level	muscular fatigue level is one of the index of electrophysiology function of pelvic floor.	6 months after delivery
muscular fatigue level	muscular fatigue level is one of the index of electrophysiology function of pelvic floor.	12 months after delivery
myoelectric potential	myoelectric potential is one of the index of electrophysiology function of pelvic floor.	42 days after delivery
myoelectric potential	myoelectric potential is one of the index of electrophysiology function of pelvic floor.	6 months after delivery
myoelectric potential	myoelectric potential is one of the index of electrophysiology function of pelvic floor.	12 months after delivery
A3 reflex	A3 reflex is one of the index of urinary continence function of pelvic floor.	42 days after delivery
A3 reflex	A3 reflex is one of the index of urinary continence function of pelvic floor.	6 months after delivery
A3 reflex	A3 reflex is one of the index of urinary continence function of pelvic floor.	12 months after delivery
dynamic pressure of pelvic floor	dynamic pressure of pelvic floor is one of the index of urinary continence function.	42 days after delivery
dynamic pressure of pelvic floor	dynamic pressure of pelvic floor is one of the index of urinary continence function.	6 months after delivery
dynamic pressure of pelvic floor	dynamic pressure of pelvic floor is one of the index of urinary continence function.	12 months after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
change from baseline in PFIQ-7 scores	42 days after delivery
change from baseline in PFIQ-7 scores	6 months after delivery
change from baseline in PFIQ-7 scores	12 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
in subjects sexually active at baseline, assessment of sexual function using PISQ-12	12 months after delivery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 17, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 20, 2013

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: pumch-gyn-06