VNOTES Approach in Mesh Free Sacrocolpopexy: A Functional and Anatomic Evaluation

NCT07114029 | Recruiting

• 1 other identifier: gopvnotes
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effectiveness of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. Anatomical and functional outcomes will be assessed over a 6-month period before and after the operation. Evaluation tools will include the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Organ Prolapse Quantification (POP-Q) system, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The findings of this study are expected to provide important data on the anatomical improvement, functional outcomes, and impact on sexual function of mesh-free sacrocolpopexy performed via the VNOTES approach.

Conditions

Pelvic Organ Prolapse

Keywords

sacrocolpopexy; mesh-free

Outcome Measures

Primary Outcomes (3)

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

  Change in pelvic floor symptom distress measured by PFDI-20 questionnaire.

  Baseline to 6 months postoperative

• Pelvic Organ Prolapse Quantification (POP-Q) Score Change

  Change in anatomical prolapse stage evaluated by POP-Q scoring system.

  Baseline to 6 months postoperative

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) Score Change

  Change in sexual function assessed by PISQ-12 questionnaire.

  Baseline to 6 months postoperative

Study Arms (1)

Mesh-free Sacrocolpopexy via VNOTES

EXPERIMENTAL

Mesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery.

Procedure: Mesh-free Sacrocolpopexy via VNOTES

Interventions

Mesh-free Sacrocolpopexy via VNOTES PROCEDURE

Mesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery.

Mesh-free Sacrocolpopexy via VNOTES

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 Gaziosmanpasa Education and Research Hospital, Gynecology and Obstetrics Clinic, have apical and anterior POP Q stage 2 and above, and have undergone surgery due to symptomatic pelvic organ prolapse, Patients who are over the age of 18 and who are citizens of the Republic of Turkey, and who have undergone surgery by experienced surgeons will be included in the study.

You may not qualify if:

• Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to prolapse Patients with severe cardiovascular or respiratory diseases will not be included in the study.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (2)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Gaziosmanpaşa 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, professor

  Gaziosmanpasa Training and Research Hospital

  STUDY DIRECTOR

• havva betül bacak, md

  Gaziosmanpasa Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yağmur acıyiyen, md

CONTACT

+905425669593; yagmuraciyiyen95@gmail.com

ecenur çelikoğlu, md

CONTACT

+905385492848; ecenucelikoglu14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, single-center interventional study designed to evaluate the anatomical and functional outcomes of mesh-free sacrocolpopexy performed via the VNOTES technique in patients with pelvic organ prolapse. All participants will undergo the same surgical intervention without randomization or a comparator arm. Preoperative and postoperative evaluations will be conducted using standardized tools over a 6-month follow-up period. The study is open-label, with no masking applied.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 11, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)