Mesh-free sacrocolpopexy using the VNOTES (transvaginal endoscopic) approach for pelvic organ prolapse
Anatomic and Functional Comparison of Preoperative and Postoperative Outcomes of Mesh Free Sacrocolpopexy Performed Via Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT07114029 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.