- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926314
The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction
August 19, 2013 updated by: Peking Union Medical College Hospital
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lan Zhu
- Phone Number: 86-10-69156238
- Email: zhu_julie@sina.com
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
|
Active Comparator: usual home care without device
Patients in this group will receive 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
Time Frame: 42 days after delivery
|
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
Time Frame: 6 months after delivery
|
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
Time Frame: 12 months after delivery
|
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
Time Frame: 42 days after delivery
|
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
Time Frame: 6 months after delivery
|
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
Time Frame: 12 months after delivery
|
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
|
12 months after delivery
|
muscular fatigue level
Time Frame: 42 days after delivery
|
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
|
42 days after delivery
|
muscular fatigue level
Time Frame: 6 months after delivery
|
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
|
6 months after delivery
|
muscular fatigue level
Time Frame: 12 months after delivery
|
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
|
12 months after delivery
|
myoelectric potential
Time Frame: 42 days after delivery
|
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
|
42 days after delivery
|
myoelectric potential
Time Frame: 6 months after delivery
|
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
|
6 months after delivery
|
myoelectric potential
Time Frame: 12 months after delivery
|
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
|
12 months after delivery
|
A3 reflex
Time Frame: 42 days after delivery
|
A3 reflex is one of the index of urinary continence function of pelvic floor.
|
42 days after delivery
|
A3 reflex
Time Frame: 6 months after delivery
|
A3 reflex is one of the index of urinary continence function of pelvic floor.
|
6 months after delivery
|
A3 reflex
Time Frame: 12 months after delivery
|
A3 reflex is one of the index of urinary continence function of pelvic floor.
|
12 months after delivery
|
dynamic pressure of pelvic floor
Time Frame: 42 days after delivery
|
dynamic pressure of pelvic floor is one of the index of urinary continence function.
|
42 days after delivery
|
dynamic pressure of pelvic floor
Time Frame: 6 months after delivery
|
dynamic pressure of pelvic floor is one of the index of urinary continence function.
|
6 months after delivery
|
dynamic pressure of pelvic floor
Time Frame: 12 months after delivery
|
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
Time Frame: 42 days after delivery
|
42 days after delivery
|
change from baseline in PFIQ-7 scores
Time Frame: 6 months after delivery
|
6 months after delivery
|
change from baseline in PFIQ-7 scores
Time Frame: 12 months after delivery
|
12 months after delivery
|
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Time Frame: 42 days after delivery
|
42 days after delivery
|
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Time Frame: 6 months after delivery
|
6 months after delivery
|
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Time Frame: 12 months after delivery
|
12 months after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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