Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse
Not Applicable
Completed
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Procedure: Laparoscopic procedure
- Registration Number
- NCT02911584
- Brief Summary
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
- Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Exclusion Criteria
- Age > 70 years
- Severe cardiovascular or respiratory disease
- Pregnancy
- Previous surgical procedure for POP correction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description POPS Laparoscopic procedure Laparoscopic procedure: Pelvic Organs Prolapse Suspension Sacral colpopexy Laparoscopic procedure Laparoscopic procedure
- Primary Outcome Measures
Name Time Method Number of patients with anatomical correction of the prolapse up to 6 months Anatomical correction of the prolapse evaluated by gynecological visit
- Secondary Outcome Measures
Name Time Method Post operative quality of life up to 6 months Subjective satisfaction of the patient evaluated by a quality of life questionnaire.
Rate of recurrence up to 6 months