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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Primiparous Women With Singleton Baby at Term

Treatments: Device: PHENIX Neuromuscular Stimulation Therapy System device; Other: usual home care without device

Study type: Interventional

Funder types: Other

Identifiers

NCT01926314

pumch-gyn-06

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,000 participants in 2 patient groups

device

Experimental group

Description:

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.

Treatment:

Device: PHENIX Neuromuscular Stimulation Therapy System device

usual home care without device

Active Comparator group

Description:

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

Treatment:

Other: usual home care without device