Comparison of Mesh-Based and Mesh-Free Laparoscopic Pectopexy in Uterus-Preserving Surgery for Apical Prolapse

NCT07080957 | Completed

• 1 other identifier: gopMeshBasedMeshFreepecto
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study compares anatomical and functional outcomes of mesh-based and mesh-free laparoscopic uterus-preserving pectopexy in women with apical pelvic organ prolapse. A total of 81 patients were included between 2021 and 2024 (mesh-based: 41, mesh-free: 40). Key outcomes assessed included operative time, blood loss, hospital stay, anatomical correction (POP-Q), sexual function (PISQ-12), and complications. Both techniques significantly improved prolapse and sexual function. Mesh-based pectopexy offered superior apical and posterior support, while mesh-free pectopexy was associated with longer vaginal length and longer operative time. Complication and recurrence rates were low and similar across groups. The findings suggest that both techniques are effective, and surgical approach should be tailored to patient preference and clinical context.

Conditions

Pelvic Organ Prolapse

Keywords

Laparoscopic Pectopexy; Apical Prolapse

Outcome Measures

Primary Outcomes (2)

• Anatomical Success According to POP-Q System

  Anatomical success is defined as apical pelvic support at stage 0 or I according to the Pelvic Organ Prolapse Quantification (POP-Q) system. Specific points evaluated include C (cervix or vaginal cuff), D (posterior fornix if applicable), Ba, Bp, and TVL (total vaginal length). Success indicates restored apical support without need for additional surgical intervention or evidence of recurrence at 1-year follow-up.

  1 year postoperatively

• Change in Sexual Function Based on PISQ-12 Score

  Sexual function was evaluated using the validated Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Scores range from 0 to 48, with higher scores indicating better sexual function. The primary endpoint was the change in total PISQ-12 score from baseline (preoperative) to 1 year postoperative. Improvements were compared between the mesh-based and mesh-free pectopexy groups to assess functional recovery related to sexual health.

  Baseline to 1 year postoperatively

Study Arms (2)

Mesh-free laparoscopic uterus-preserving pectopexy

ACTIVE COMPARATOR

Patients in this group underwent laparoscopic uterus-preserving pectopexy without the use of synthetic mesh. Instead, native tissue fixation techniques were employed to achieve apical support. The uterus was preserved in all cases. Follow-up was conducted at 6 weeks, 3 months, and 1 year to evaluate outcomes.

Procedure: Mesh-free laparoscopic uterus-preserving pectopexy

Mesh-based laparoscopic uterus-preserving pectopexy

ACTIVE COMPARATOR

Patients in this group underwent laparoscopic uterus-preserving pectopexy using synthetic mesh for apical support. The mesh was fixed bilaterally to the iliopectineal ligaments to restore apical support while preserving the uterus. Outcomes were assessed preoperatively and at 6 weeks, 3 months, and 1 year postoperatively.

Procedure: Mesh-based laparoscopic uterus-preserving pectopexy

Interventions

Mesh-free laparoscopic uterus-preserving pectopexy PROCEDURE

Laparoscopic pectopexy without synthetic mesh was performed by utilizing native tissue fixation techniques. The uterus was suspended to the iliopectineal ligaments using permanent sutures without mesh implantation. The procedure aimed to provide apical support and avoid mesh-related complications. Postoperative follow-up included assessments of anatomical correction, functional recovery, and patient satisfaction.

Mesh-free laparoscopic uterus-preserving pectopexy

Mesh-based laparoscopic uterus-preserving pectopexy PROCEDURE

Laparoscopic pectopexy was performed using a synthetic mesh to provide apical support while preserving the uterus. The mesh was bilaterally fixed to the iliopectineal (Cooper's) ligaments, and the uterus was suspended in a tension-free manner. This technique is designed to restore pelvic anatomy and improve symptoms of prolapse. Patients were followed postoperatively to assess anatomical success, complications, and functional outcomes.

Mesh-based laparoscopic uterus-preserving pectopexy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of pelvic organ prolapse (POP) classified as stage 2 or higher according to the POP-Q (Pelvic Organ Prolapse Quantification) system
• Desire for uterus preservation and refusal of hysterectomy during surgery
• Eligible for surgical intervention and able to undergo general anesthesia
• Women aged 18 years and older with pelvic organ prolapse

You may not qualify if:

• History of hysterectomy
• Severe comorbidities (e.g., serious cardiovascular diseases, bleeding disorders, or other medical conditions that may interfere with surgical treatment)
• Active infections in the pelvic or urogenital region
• Advanced malignancies (e.g., cancer)
• Psychological or cognitive impairments preventing informed consent or compliance with postoperative follow-up

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• enes serhat coşkun, md

  University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Obstetrics and Gynecology

Model Details: This is a single-center, retrospective cohort study designed to compare two surgical techniques-mesh-based and mesh-free laparoscopic uterus-preserving pectopexy-in patients diagnosed with apical pelvic organ prolapse. Data were collected from medical records of patients operated between 2021 and 2024. Participants were divided into two groups based on the type of surgical procedure received. Outcomes including anatomical correction, sexual function, operative time, complications, and recurrence were assessed using standardized instruments such as the POP-Q system and the PISQ-12 questionnaire. No randomization or blinding was applied due to the retrospective nature of the study.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: April 16, 2025
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)