A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment; Procedure: laparoscopic sacral colpopexy with posterior mesh attachment

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maurizio Guido; Phone Number: 3393894243; Email: maurizioguido@libero.it

Study Locations

• Italy
  • Bari
    • Acquaviva delle Fonti, Bari, Italy, 70021
      • Recruiting
      • ospedale regionale Miulli
      • Contact: Maurizio Guido, PhD; Phone Number: 3393894243; Email: maurizioguido@libero.it
      • Principal Investigator: Maurizio Guido, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: posterior mesh no attachment; laparoscopic sacral colpopexy with no fixation of posterior mesh	Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment; pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
Active Comparator: posterior mesh attachment; laparoscopic sacral colpopexy with fixation of posterior mesh by suture	Procedure: laparoscopic sacral colpopexy with posterior mesh attachment; pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correction of pelvic organ prolapse	number of women with correction of prolapse mesured in S POP-Q stage during FU visit	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of recurrence	number of women with de novo anterior or posterior or central prolapse	1 year
long term outcomes	number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain	1 year

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Miulli General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Ospedale "F. Miulli"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No