Comparing the effects of two types of surgeries including uterosacral and sacrospinous ligament stabilization for the treatment of pelvic floor disorders

Phase 2

Recruiting

• Conditions: Pelvic organ prolapse.; N81.3; Complete uterovaginal prolapse

• Registration Number: IRCT20200825048515N21
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Recurrence of the disease. Timepoint: 12 months after surgery. Method of measurement: Clinical examination and Pelvic Floor Distress Inventory questionnaire (PFDI-20).