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IRCT20200825048515N21 IRCT 2021-01-18 Esfahan University of Medical Sciences Comparing the effects of two types of surgeries including uterosacral and sacrospinous ligament stabilization for the treatment of pelvic floor disorders Comparative study of uterosacral and sacrospinous ligament stabilization surgeries for the treatment of pelvic floor disorders 2021-01-20 anticipated 64 Complete https://irct.ir/trial/53477 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 64 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: Due to the nature of the present study, the surgeon is aware of the type of surgery in each of the two groups, but the patient and the evaluator (data collector) are not aware of the type of surgery in each group. 2 Pelvic organ prolapse. Intervention 1: First intervention group: Patients in this group as the first group undergo uterosacral surgery. Intervention 2: Second intervention group: Patients in this group as the first group undergo sacrospinous surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Maryam Hajhashemi
Motahari Street.
Isfahan Iran (Islamic Republic of) 8184853541 +98 31 3234 6338 hajhashemy73@yahoo.com Esfahan University of Medical Sciences scientific Maryam Hajhashemi
Motahari Street.
Isfahan Iran (Islamic Republic of) 8184853541 +98 31 3234 6338 hajhashemy73@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The age between 18 and 75 years old Cervical prolapse grade two or more based on examination Symptomatic prolapse for protrusion or intestinal or urinary symptoms Lack of response to conservative treatments Demand for surgical treatment for prolapse Being consent to participate in the study 18 years 75 years Both Contraindication to major surgery or anesthesia Existence of any malignancy in the urinary, genital and pelvic systems Active infection of the urinary, genital and pelvic systems Pregnancy and breastfeeding N81.3 Complete uterovaginal prolapse Treatment - Surgery Treatment - Surgery First intervention group: Patients in this group as the first group undergo uterosacral surgery. Second intervention group: Patients in this group as the first group undergo sacrospinous surgery Pelvic floor muscle function. Timepoint: Before and 12 months after the intervention. Method of measurement: Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20). Sexual function. Timepoint: Before and 12 months after the intervention. Method of measurement: Female Sexual Function Index (FSFI) questionnaire. Recurrence of the disease. Timepoint: 12 months after surgery. Method of measurement: Clinical examination and Pelvic Floor Distress Inventory questionnaire (PFDI-20). Isfahan University of Medical Sciences Approved 2020-11-26 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave, Azadi Square. Isfaha Isfehan Iran (Islamic Republic of)