Investigating the success rate of using human acellular tissue in reconstructive surgeries in women with anterior or apical pelvic prolapse
Not Applicable
- Conditions
- pelvic prolapse.Female genital prolapse
- Registration Number
- IRCT20180409039247N5
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.