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

Study Overview
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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.

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

Conditions
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Primiparous Women With Singleton Baby at Term

Intervention / Treatment
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* Device: PHENIX Neuromuscular Stimulation Therapy System device
* Other: usual home care without device


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: device<br>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<br> <br> |
| Active Comparator: usual home care without device<br>Patients in this group will receive usual home care without device. | Other: usual home care without device<br> <br> |

What is the study measuring?
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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 | Measure Description | 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 |