pelvic prolapse. Female genital prolapse
Conditions
Interventions
Intervention 1: Intervention group: Using human acellular tissue in surgical repair in anterior and apical prolapse. Intervention 2: Control group: Surgical repair in anterior and apical prolapse usin
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women over 18 years of age Patients with prolapse of the anterior and/or apical compartment stage 2 and above, which has caused complaints including the feeling of engorgement, mass discharge, and urination disorders. candidate for reconstructive surgery
Exclusion criteria
Exclusion criteria: History of pelvic floor reconstruction surgery and urinary incontinence surgery Uncontrolled diabetes Any vaginal or abdominal surgery requires the use of mesh Immunity deficiency or high dose corticosteroid use Smoking or using hookah
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: surgical success, 12 months after surgery, absence of prolapse beyond hymen in any compartment. Timepoint: before the intervention and 12 months after the intervention. Method of measurement: standard pelvic organ prolapse measurement system (POPQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| PFDI20 questionnaire. Timepoint: before and 12 months after intervention. Method of measurement: Questionnaire score, This questionnaire has three parts: intestinal (CRAD-8), bladder (UDI-6) and pelvic (PODI-6) symptoms. Each question in each part has a score between 0-4. 0 means no complaint and 4 means it is extremely uncomfortable. The items of each comparison will be added, multiplied by 25 and divided by the number of questions. Therefore, the score of each part will be between 0-100. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZinat Ghanbari
Tehran University of Medical Sciences
Outcome results
None listed