NCT07114029

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

Anatomic and Functional Comparison of Preoperative and Postoperative Outcomes of Mesh Free Sacrocolpopexy Performed Via Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Gaziosmanpasa Research and Education Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective clinical study investigates the anatomical and functional outcomes of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. The VNOTES approach allows transvaginal access to the pelvic cavity without the need for abdominal incisions, offering the advantages of minimally invasive surgery while avoiding the use of synthetic mesh. The study includes women diagnosed with stage II or higher pelvic organ prolapse who are candidates for sacrocolpopexy via the VNOTES technique. All participants will undergo mesh-free sacrocolpopexy performed transvaginally using endoscopic guidance. Anatomical and functional outcomes will be evaluated using validated tools, including the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Assessments will be performed preoperatively and at 6 months postoperatively. Intraoperative data such as operative time, estimated blood loss, complications, and length of hospital stay will also be collected. The primary goal of the study is to assess anatomical success based on changes in POP-Q staging. Secondary outcomes include improvements in pelvic floor symptoms, sexual function, recurrence rates, and patient satisfaction. This study aims to provide evidence on the safety, feasibility, and functional benefits of performing sacrocolpopexy without mesh through the VNOTES approach in the management of advanced pelvic organ prolapse.

Conditions

• Pelvic Organ Prolapse

Interventions

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

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

2 sites across 1 country: Turkey (Türkiye)