POP
Conditions
Interventions
experimental group:Zhuoruan Medical biological hernia repair mesh
Sponsors
Tongji Hosiptal of Tongji University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Primary pelvic organ prolapse; 2. Major vaginal prolapse margins (i.e., more severe prolapse) >=POP-Q 2 or >=POP-Q 2 from the anterior and posterior vaginal wall; 3. At least 1 prolapse related symptom (including but not limited to: vaginal puffin, vaginal pain/discomfort, dysfunction of urination, manual reduction after defecation (Digitation), fecal incontinence, painful sexual intercourse).
Exclusion criteria
Exclusion criteria: 1. Aged 40; 3. Associated with an active vaginal or urinary infection, or with a systemic infection; 4. Vaginal atrophy (note: patients with vaginal atrophy may be enrolled after receiving effective treatment); 5. Prior synthetic patch or biological patch implantation due to pelvic organ prolapse; 6. A prior history of cervical, ovarian, uterine, endometrial, vaginal, colon, rectal, or bladder cancer; 7. Occlusive repair surgery for pelvic organ prolapse is currently planned; 8. Long-term immunosuppressive therapy, including glucocorticoids or cytotoxic drugs, is required; 9. Previous diagnosis of collagenopathy (i.e. Marfan syndrome, congenital connective tissue dysplasia syndrome); 10. Evaluation or treatment of chronic pelvic diseases (such as interstitial cystitis, endometriosis, vulvar pain, pain due to pelvic congestion syndrome) is currently under way; 11. A history of pelvic infectious disease; 12. Patients during pregnancy and lactation; 13. Allergy to or cultural rejection of pig products; 14. Life expectancy is less than 12 months; 15. Participating in a research device or drug trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POPQ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective recurrence rate;Patch exposed;Patch erosion;Pelvic pain;infection;Sexual intercourse pain;Vaginal shortening;Vaginal scar;Vaginal bleeding;Abnormal vaginal discharge;Fistula formation;Micturition function;Neuromuscular complications;PFIQ-7;PISQ-12;PFDI-20; | — |
Countries
China
Contacts
Public ContactOuyang Yiqin; Zhang Kun
Tongji Hosiptal of Tongji University
Outcome results
None listed