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

N/AUnknownNCT01926314

Peking Union Medical College Hospital1,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,000

Conditions

Primiparous Women With Singleton Baby at Term

Interventions

PHENIX Neuromuscular Stimulation Therapy System deviceDEVICE

usual home care without deviceOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Foshan maternal and child health hospital

Foshan, Guangdong, China

RECRUITING

The first affiliated hospital of Guangzhou medical college

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

strength of deep muscle fiber I

Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months after delivery

muscular fatigue level

muscular fatigue level is one of the index of electrophysiology function of pelvic floor.

Time frame: 42 days after delivery

muscular fatigue level

muscular fatigue level is one of the index of electrophysiology function of pelvic floor.

Central Contacts

Lan Zhu

CONTACT

86-10-69156238 zhu_julie@sina.com

Data from ClinicalTrials.gov

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Secondary Outcomes

change from baseline in PFIQ-7 scores

Time frame: 42 days after delivery

change from baseline in PFIQ-7 scores

Time frame: 6 months after delivery

change from baseline in PFIQ-7 scores

Time frame: 12 months after delivery

in subjects sexually active at baseline, assessment of sexual function using PISQ-12

Time frame: 42 days after delivery

in subjects sexually active at baseline, assessment of sexual function using PISQ-12

Time frame: 6 months after delivery

in subjects sexually active at baseline, assessment of sexual function using PISQ-12

Time frame: 12 months after delivery