Female Pelvic Function Disorder
Conditions
Interventions
Treatment Group:Use collagen I gel in vagina once a night, 10 days a month, for three consecutive months
Control Group:The routine living habits of pelvic organ prolapse and urinary incontinence and family Kegel training guidance were given for 3 months.
Sponsors
Shanghai 10th People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 = 18 years old, subject voluntarily enters the clinical trial with informed consent 2. Mild and moderate pelvic floor dysfunction diseases (including mild and moderate vaginal wall prolapse/relaxation, uterine prolapse, urinary incontinence, frequency of urination, etc.) 3. Good compliance, treatment can be completed according to the doctor's instructions, and close follow-up is available
Exclusion criteria
Exclusion criteria: 1. Active vaginal infection or urinary system infection, or systemic infection; 2. In the past, synthetic or biological patches were implanted due to pelvic organ prolapse; 3. Previous medical history of cervical cancer, ovarian cancer, uterine cancer, endometrial cancer, vaginal cancer, colon cancer, rectal cancer or bladder cancer; 4. Occlusive repair of pelvic organ prolapse is currently planned; 5. Long-term use of immunosuppressive therapy, including glucocorticoids or cytotoxic drugs; 6. Previously diagnosed as collagen disease (i.e. Marfan syndrome, congenital connective tissue dysplasia syndrome); 7. Currently, the assessment or treatment of chronic pelvic diseases (such as interstitial cystitis, endometriosis, vulval pain, pain caused by pelvic congestion syndrome) is under way; 8. Have a history of pelvic infectious diseases; 9. Pregnancy and lactation patients; 10. The expected life is less than 12 months; 11. Participating in other device or drug tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the MOS item short from health survey (SF-36);pelvic floor distress inventory-short form 20 (PFDI-20);ICI Questionnaire-Short Form, (ICIQ-SF)/overactive bladder syndrome score (OABss);Validation of the Chinese version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12); | — |
Secondary
| Measure | Time frame |
|---|---|
| vaginal health index score (VHIS);Electrophysiological examination of pelvic floor function;POP-Q measurement;pelvic physical examination; | — |
Countries
China
Contacts
Public ContactRong Chen
Shanghai 10th People's Hospital
Outcome results
None listed