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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primiparous Women With Singleton Baby at Term

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PHENIX Neuromuscular Stimulation Therapy System device

Intervention Type DEVICE

usual home care without device

Patients in this group will receive usual home care without device.

Group Type ACTIVE_COMPARATOR

usual home care without device

Intervention Type OTHER

Interventions

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PHENIX Neuromuscular Stimulation Therapy System device

Intervention Type DEVICE

usual home care without device

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes