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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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

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Pelvic Organ Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mesh-free Sacrocolpopexy via VNOTES

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No