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A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
laparoscopic sacral colpopexy with posterior mesh no attachment
laparoscopic sacral colpopexy with posterior mesh attachment
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

undefined - 75 Years (Child, 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 > 75 years
  • Severe cardiovascular or respiratory disease
  • Pregnancy

Sites / Locations

  • ospedale regionale MiulliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

posterior mesh no attachment

posterior mesh attachment

Arm Description

laparoscopic sacral colpopexy with no fixation of posterior mesh

laparoscopic sacral colpopexy with fixation of posterior mesh by suture

Outcomes

Primary Outcome Measures

correction of pelvic organ prolapse
number of women with correction of prolapse mesured in S POP-Q stage during FU visit

Secondary Outcome Measures

rate of recurrence
number of women with de novo anterior or posterior or central prolapse
long term outcomes
number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain

Full Information

First Posted
April 21, 2020
Last Updated
July 22, 2020
Sponsor
Catholic University of the Sacred Heart
Collaborators
Miulli General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04358978
Brief Title
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy
Official Title
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Miulli General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.

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
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
posterior mesh no attachment
Arm Type
Active Comparator
Arm Description
laparoscopic sacral colpopexy with no fixation of posterior mesh
Arm Title
posterior mesh attachment
Arm Type
Active Comparator
Arm Description
laparoscopic sacral colpopexy with fixation of posterior mesh by suture
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sacral colpopexy with posterior mesh no attachment
Intervention Description
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sacral colpopexy with posterior mesh attachment
Intervention Description
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina
Primary Outcome Measure Information:
Title
correction of pelvic organ prolapse
Description
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
Time Frame
1 year
Secondary Outcome Measure Information:
Title
rate of recurrence
Description
number of women with de novo anterior or posterior or central prolapse
Time Frame
1 year
Title
long term outcomes
Description
number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain
Time Frame
1 year

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
75 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 > 75 years Severe cardiovascular or respiratory disease Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maurizio Guido
Phone
3393894243
Email
maurizioguido@libero.it
Facility Information:
Facility Name
ospedale regionale Miulli
City
Acquaviva delle Fonti
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Guido, PhD
Phone
3393894243
Email
maurizioguido@libero.it
First Name & Middle Initial & Last Name & Degree
Maurizio Guido, PhD

12. IPD Sharing Statement

Learn more about this trial

A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

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