Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Laparoscopic procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02911584

CSP1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Sacral colpopexy

Active Comparator group

Description:

Laparoscopic procedure

Treatment:

Procedure: Laparoscopic procedure

POPS

Active Comparator group

Description:

Laparoscopic procedure: Pelvic Organs Prolapse Suspension

Treatment:

Procedure: Laparoscopic procedure