Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques

NCT07082023 | Recruiting

• 1 other identifier: gopvnotessacrocolpopexy
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. By evaluating perioperative data, complication rates, anatomical and functional outcomes, this trial seeks to determine whether the V-NOTES approach provides comparable or superior results to the traditional laparoscopic technique, without the use of synthetic mesh.

Conditions

Pelvic Organ Prolapse

Keywords

Sacrocolpopexy; vNOTES

Outcome Measures

Primary Outcomes (3)

• Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months

  Anatomical success will be evaluated using the POP-Q system. A reduction of prolapse stage by at least one level or achieving stage 0-1 will be considered successful.

  Baseline and 6 months postoperative

• Change in PISQ-12 Score

  Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.

  Baseline and 6 months postoperative

• Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score

  Patient-reported symptoms related to pelvic floor distress will be evaluated using the PFDI-20. A decrease in score indicates improvement in symptoms.

  Baseline and 6 months postoperative

Study Arms (2)

V-NOTES Sacrocolpopexy

EXPERIMENTAL

Patients undergoing mesh-free sacrocolpopexy via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).

Procedure: V-NOTES Mesh-Free Sacrocolpopexy

Laparoscopic Sacrocolpopexy

ACTIVE COMPARATOR

Patients undergoing mesh-free sacrocolpopexy via conventional laparoscopy.

Procedure: Laparoscopic Mesh-Free Sacrocolpopexy

Interventions

V-NOTES Mesh-Free Sacrocolpopexy PROCEDURE

Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).

V-NOTES Sacrocolpopexy

Laparoscopic Mesh-Free Sacrocolpopexy PROCEDURE

Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Laparoscopic Sacrocolpopexy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who applied to Gaziosmanpaşa Education and Research Hospital, Gynecology and Obstetrics Clinic, who underwent surgery due to symptomatic pelvic organ prolapse with apical and anterior POP Q stage 2 and above, Being over 18 years old Patients who underwent surgery by experienced surgeons

You may not qualify if:

• Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to proplasus Patients with severe cardiovascular or respiratory disease

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• süleyman salman, prof

  Gaziosmanpaşa Training and Research Hospital

  STUDY DIRECTOR

• havva betül bacak, md

  Gaziosmanpaşa Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ecenur çelikoğlu, md

CONTACT

+90 538 54 92 848; ecenurcelikoglu14@gmail.com

yağmur acıyiyen, md

CONTACT

+90 542 566 9593; yagmuraciyiyen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: md

Model Details: This is a prospective, interventional, randomized, parallel-group clinical trial comparing two minimally invasive surgical techniques for pelvic organ prolapse repair: V-NOTES sacrocolpopexy and laparoscopic sacrocolpopexy, both performed without synthetic mesh. Participants will be randomly assigned (1:1) to either group. The study aims to evaluate outcomes using validated tools including POP-Q, PFDI-20, and PISQ-12 over a 6-month follow-up period.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 24, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)