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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01926314
First received: August 17, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Primiparous Women With Singleton Baby at Term
Device: PHENIX Neuromuscular Stimulation Therapy System device
Other: usual home care without device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • strength of deep muscle fiber I [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
    Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.

  • strength of deep muscle fiber I [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.

  • strength of deep muscle fiber I [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
    Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.

  • strength of deep muscle fiber II [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
    Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.

  • strength of deep muscle fiber II [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.

  • strength of deep muscle fiber II [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
    Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.

  • muscular fatigue level [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
    muscular fatigue level is one of the index of electrophysiology function of pelvic floor.

  • muscular fatigue level [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    muscular fatigue level is one of the index of electrophysiology function of pelvic floor.

  • muscular fatigue level [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
    muscular fatigue level is one of the index of electrophysiology function of pelvic floor.

  • myoelectric potential [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
    myoelectric potential is one of the index of electrophysiology function of pelvic floor.

  • myoelectric potential [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    myoelectric potential is one of the index of electrophysiology function of pelvic floor.

  • myoelectric potential [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
    myoelectric potential is one of the index of electrophysiology function of pelvic floor.

  • A3 reflex [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
    A3 reflex is one of the index of urinary continence function of pelvic floor.

  • A3 reflex [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    A3 reflex is one of the index of urinary continence function of pelvic floor.

  • A3 reflex [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
    A3 reflex is one of the index of urinary continence function of pelvic floor.

  • dynamic pressure of pelvic floor [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
    dynamic pressure of pelvic floor is one of the index of urinary continence function.

  • dynamic pressure of pelvic floor [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    dynamic pressure of pelvic floor is one of the index of urinary continence function.

  • dynamic pressure of pelvic floor [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
    dynamic pressure of pelvic floor is one of the index of urinary continence function.


Secondary Outcome Measures:
  • change from baseline in PFIQ-7 scores [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
  • change from baseline in PFIQ-7 scores [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
  • change from baseline in PFIQ-7 scores [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
  • in subjects sexually active at baseline, assessment of sexual function using PISQ-12 [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
  • in subjects sexually active at baseline, assessment of sexual function using PISQ-12 [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
  • in subjects sexually active at baseline, assessment of sexual function using PISQ-12 [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: PHENIX Neuromuscular Stimulation Therapy System device
Active Comparator: usual home care without device
Patients in this group will receive usual home care without device.
Other: usual home care without device

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926314

Contacts
Contact: Lan Zhu 86-10-69156238 zhu_julie@sina.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Lan Zhu    86-10-69156238    zhu_julie@sina.com   
Principal Investigator: Lan Zhu         
China, Guangdong
Foshan maternal and child health hospital Recruiting
Foshan, Guangdong, China, 528000
Contact: Yuling Wang    86-13049161630    wujun701121@126.com   
Principal Investigator: Yuling Wang         
The first affiliated hospital of Guangzhou medical college Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Xiaowei Zhang    86-13609086710    xwzhang81341235@163.com   
Contact: xiaowei zhang    86-13609086710    xwzhang81341235@163.com   
Principal Investigator: xiaowei zhang         
China, Jiangsu
Wuxi Maternal and Child Health Hospital, Nanjing Medical University Recruiting
Wuxi, Jiangsu, China, 214002
Contact: Jian Gong       gongjianwx@126.com   
Principal Investigator: Jian Gong         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01926314     History of Changes
Other Study ID Numbers: pumch-gyn-06
Study First Received: August 17, 2013
Last Updated: August 19, 2013
Health Authority: China: Ministry of Health

ClinicalTrials.gov processed this record on November 25, 2014