Pelvic Organ Prolapse
Conditions
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.
Interventions
PROCEDURELaparoscopic procedure
Sponsors
Miulli General Hospital
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with anatomical correction of the prolapse | up to 6 months | Anatomical correction of the prolapse evaluated by gynecological visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrence | up to 6 months | — |
| Post operative quality of life | up to 6 months | Subjective satisfaction of the patient evaluated by a quality of life questionnaire. |
Outcome results
None listed