Clinical trial Recruiting at 2 sites Interventional Ages 18 to 75 Women only

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 typeInterventional
Ages18 Years to 75 Years
SexWomen only
Enrollment26 (estimated)
SponsorGaziosmanpasa Research and Education Hospital
Government
Locations2 sites (Istanbul and 1 other locations)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedJanuary 1, 2026
Study endsJanuary 1, 2026
Registry record updatedAugust 11, 2025
Trial IDNCT07114029 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.