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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| device | Experimental | 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. |
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| usual home care without device | Active Comparator | Patients in this group will receive usual home care without device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHENIX Neuromuscular Stimulation Therapy System device | Device |
| ||
| usual home care without device |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 86-10-69156238 | zhu_julie@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Other |
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| 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 |
| 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 |
| Foshan maternal and child health hospital | Recruiting | Foshan | Guangdong | 528000 | China |
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| The first affiliated hospital of Guangzhou medical college | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Wuxi Maternal and Child Health Hospital, Nanjing Medical University | Recruiting | Wuxi | Jiangsu | 214002 | China |
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