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Recruiting NCT07114029

NCT07114029 VNOTES Approach in Mesh Free Sacrocolpopexy: A Functional and Anatomic Evaluation

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Clinical Trial Summary
NCT ID NCT07114029
Status Recruiting
Phase
Sponsor Gaziosmanpasa Research and Education Hospital
Condition Pelvic Organ Prolapse
Study Type INTERVENTIONAL
Enrollment 26 participants
Start Date 2025-07-01
Primary Completion 2026-01-01

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Mesh-free Sacrocolpopexy via VNOTES

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 26 participants in total. It began in 2025-07-01 with a primary completion date of 2026-01-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

yağmur acıyiyen, md

✉ yagmuraciyiyen95@gmail.com

📞 +905425669593

Principal Investigator

süleyman salman, professor

STUDY DIRECTOR

Gaziosmanpasa Training and Research Hospital

Frequently Asked Questions

Who can join the NCT07114029 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07114029 currently recruiting?

Yes, NCT07114029 is actively recruiting participants. Contact the research team at yagmuraciyiyen95@gmail.com for enrollment information.

Where is the NCT07114029 trial being conducted?

This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).

Who is sponsoring the NCT07114029 clinical trial?

NCT07114029 is sponsored by Gaziosmanpasa Research and Education Hospital. The principal investigator is süleyman salman, professor at Gaziosmanpasa Training and Research Hospital. The trial plans to enroll 26 participants.

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