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Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic procedure
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sacral colpopexy

    POPS

    Arm Description

    Laparoscopic procedure

    Laparoscopic procedure: Pelvic Organs Prolapse Suspension

    Outcomes

    Primary Outcome Measures

    Number of patients with anatomical correction of the prolapse
    Anatomical correction of the prolapse evaluated by gynecological visit

    Secondary Outcome Measures

    Rate of recurrence
    Post operative quality of life
    Subjective satisfaction of the patient evaluated by a quality of life questionnaire.

    Full Information

    First Posted
    September 15, 2016
    Last Updated
    December 4, 2017
    Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Collaborators
    Miulli General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02911584
    Brief Title
    Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse
    Official Title
    Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Collaborators
    Miulli General Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sacral colpopexy
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic procedure
    Arm Title
    POPS
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic procedure: Pelvic Organs Prolapse Suspension
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic procedure
    Primary Outcome Measure Information:
    Title
    Number of patients with anatomical correction of the prolapse
    Description
    Anatomical correction of the prolapse evaluated by gynecological visit
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    Rate of recurrence
    Time Frame
    up to 6 months
    Title
    Post operative quality of life
    Description
    Subjective satisfaction of the patient evaluated by a quality of life questionnaire.
    Time Frame
    up to 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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