Pelvic floor prolapse
Conditions
Interventions
Trial group:Surgical implantation, biological pelvic floor patches
Control group:Surgical implantation,TiLOOP Products
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
Female
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria simultaneously to be eligible for inclusion. 1. Age >= 50 years and <= 75 years; 2. Anterior vaginal wall prolapse of grade III-IV (POP-Q staging), with symptoms requiring pelvic floor reconstruction surgery, may be accompanied by uterine prolapse or posterior vaginal wall prolapse simultaneously; 3. The patient voluntarily participates in the clinical trial, signs the informed consent form, and is able to cooperate with the clinical follow-up.
Exclusion criteria
Exclusion criteria: Subjects must be excluded if they meet any of the following criteria: 1. History of previous POP surgery; 2. Presence of malignant tumors; 3. Acute vaginal or pelvic infection; 4. Severe cardiac, liver, or kidney dysfunction, defined as: (1) Cardiac function: Class III or above; (2) ALT or AST > 2.5 times the upper limit of normal; (3) Serum creatinine > 2.5 times the upper limit of normal; 5. Significant coagulation abnormalities (prothrombin time prolonged >6 seconds); 6. Poorly controlled diabetes: fasting blood glucose >11.1 mmol/L after medication; 7. Presence of immunodeficiency; 8. Specific allergic constitution, such as collagen allergy; 9. Inability to accept porcine-derived materials due to religious, ethnic, or other reasons; 10. Pregnant women, women planning pregnancy, and lactating women; 11. Participation in other drug or medical device clinical trials within the past 6 months; 12. Other conditions deemed unsuitable for trial participation by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomic success rate (POP-Q staging). Anatomic success requires simultaneously meeting the following three criteria: a. Aa, Ba, Ap, Bp <= 0, and C < -1/2 TVL, based on physical examination;Denial of vaginal prolapse symptoms: PFDI-20 questionnaire question 3 score <2;No further treatment is needed for prolapse, such as additional surgery or the use of a pessary.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overactive Bladder Symptom Score;Patient Global Impression of Improvement;Pelvic Floor Distress Inventory-Short Form 20;Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-31;Visual Analogue Score; | — |
Countries
China
Contacts
Public ContactSun Xiuli
Peking University People's Hospital
Outcome results
None listed