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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorGaziosmanpasa Research and Education Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Mesh-free Sacrocolpopexy via VNOTES

    Procedure/Surgery

    Mesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Mesh-free Sacrocolpopexy via VNOTESExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change

Change in pelvic floor symptom distress measured by PFDI-20 questionnaire.

Time frame
Baseline to 6 months postoperative
2

Pelvic Organ Prolapse Quantification (POP-Q) Score Change

Change in anatomical prolapse stage evaluated by POP-Q scoring system.

Time frame
Baseline to 6 months postoperative
3

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) Score Change

Change in sexual function assessed by PISQ-12 questionnaire.

Time frame
Baseline to 6 months postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

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