Mesh-free sacrocolpopexy using the VNOTES (transvaginal endoscopic) approach for pelvic organ prolapse
Official title: Anatomic and Functional Comparison of Preoperative and Postoperative Outcomes of Mesh Free Sacrocolpopexy Performed Via Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES)
Run by Gaziosmanpasa Research and Education Hospital · NCT07114029 · Data updated 2026-11-12
This trial will try mesh-free sacrocolpopexy using the VNOTES transvaginal endoscopic technique in women with stage II or higher pelvic organ prolapse to see if it improves pelvic support, symptoms, and sexual function over six months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 26 (estimated) |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | January 1, 2026 |
| Study ends | January 1, 2026 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07114029 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who are Turkish citizens with symptomatic apical and/or anterior POP-Q stage II or higher and who are candidates for sacrocolpopexy via VNOTES at the participating hospital are ideal candidates.
✕Probably not a fit
Patients with prior prolapse surgery, prior chemotherapy/radiation for malignancy, or severe cardiovascular or respiratory disease are excluded and therefore may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective clinical study at Gaziosmanpaşa Training and Research Hospital enrolling women with apical and/or anterior POP-Q stage II or higher who are candidates for sacrocolpopexy. Participants will undergo mesh-free sacrocolpopexy performed transvaginally with endoscopic (VNOTES) guidance and all surgeries will be done by experienced surgeons. Anatomical and functional outcomes will be measured before surgery and at six months after surgery using POP-Q, PFDI-20, and PISQ-12, and intraoperative data (operative time, blood loss, complications, length of stay) will be recorded. The primary endpoint is anatomical success by POP-Q change, with secondary endpoints including symptom improvement, sexual function, recurrence, and patient satisfaction.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive, mesh-free option that restores pelvic support while avoiding synthetic mesh and possibly improving symptoms and sexual function.
How similar studies have gone: Existing case series and small cohort reports of VNOTES and mesh-free pelvic floor procedures suggest feasibility and favorable short-term outcomes, but larger or randomized data are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: havva betül bacak, md — Gaziosmanpasa Training and Research Hospital
- Study coordinator: yağmur acıyiyen, md
- Email: yagmuraciyiyen95@gmail.com
- Phone: +905425669593
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.