Multicenter Study on the Correction of Prolapse Via Laparoscopy

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Procedure: lateral laparoscopic suspension (LLS); Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle

Detailed Description

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

• Study Type: Interventional
• Enrollment (Estimated): 181
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Luisa Sánchez Ferrer, MD; Phone Number: 968369500; Email: marisasanchezferrer1@gmail.com

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • HCUVA
    • Contact: Maria Luisa Sanchez Ferrer, MD; Email: marisasanchezferrer1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.

Exclusion Criteria:

• History of abdominal prolapse reconstructive surgery.
• History of prolapse reconstructive surgery with vaginal meshes.
• Stage I according to the POP-Q classification or asymptomatic prolapse.
• Medical contraindication for general anaesthesia.
• Patient preference for vaginal surgical treatment.
• Patient does not wish to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lateral laparoscopic suspension (LLS)	Procedure: lateral laparoscopic suspension (LLS); lateral laparoscopic suspension (LLS)
Active Comparator: Sacropexy without posterior mesh fixation on the puborrectalis muscle	Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle; Sacropexy without posterior mesh fixation on the puborrectalis muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Organ Prolapse Distress Inventory	Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6	up to 12 months
Colorectal-Anal Distress Inventory	Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8	up to 12 months
Urinary Distress Inventory	Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.	up to 12 months
Number of patients with symptomatic failure	Number of patients with symptomatic failure , defined as a positive response (accompanied by any degree of discomfort) to the following question on the validated questionnaire regarding prolapse symptoms (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal and pain symptoms	Subjective or functional success is defined as an improvement of ≥15 points per domain (the minimally important difference) or a decrease in the total score of 45 points (the minimally important difference). The PISQ-2 questionnaire has a score range between 0 and 48, and a difference ≥ 6 points is considered a minimally important difference.	up to 12 months
Anatomical result	Anatomical results are defined as any POP-Q measurement below the hymen. Anatomical variables of prolapse: POPQ classification : Anterior compartment: Aa, Ba; Middle compartment: C or D; Posterior compartment: Ap, Bp	up to 12 months

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Prolapse; Pelvic Floor Disorders
• Other Study ID Numbers: 2022-3-8-HCUVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No