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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926314

Enrollment

1000

Registered

2013-08-20

Start date

2013-08-31

Completion date

2017-12-31

Last updated

2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primiparous Women With Singleton Baby at Term

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.

Interventions

DEVICEPHENIX Neuromuscular Stimulation Therapy System device

OTHERusual home care without device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactLan Zhu

zhu_julie@sina.com86-10-69156238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026