Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique

NCT05066737 | Completed

• 1 other identifier: GaziosmanpasaTREHf
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

It was aimed to evaluate the quality of life and sexual function of patients by Pre- and postoperative POP-Q (Pelvic Organ Prolapse Quantification) staging and PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) test of patients who underwent lateral suspension operation with V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; lateral suspension; v-notes; pop-q; pısq-12

Outcome Measures

Primary Outcomes (2)

• Incidence of pelvic organ prolapsus in patients undergone lateral suspension performed via V-Notes

  Assessment of pop-q quantification staging system before and 6 months after lateral suspension performed via V-notes

  6 months

• Incidence of pelvic organ prolapse/urinary Incontinence and sexual function in patients undergone lateral suspension performed via V-Notes

  Assessment of pisq-12 Questionnaire in patients undergone lateral suspension performed via V-Notes

  6 months

Study Arms (1)

patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery

EXPERIMENTAL

Procedure: lateral suspension via V-NOTES surgery

Interventions

lateral suspension via V-NOTES surgery PROCEDURE

pop-q, pisq-12 assesment of patients with pelvic organ prolapse before and 6 or 12 month after lateral suspension surgery performed via V-NOTES technique.

patients who has pelvic organ prolapse and underwent lateral suspension via V-notes surgery

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with more than 2nd and 3rd degree uterine prolapsus
• Patients with more than 2nd and 3rd degree cystocele

You may not qualify if:

• Having endometriosis
• Having a history and/ or active pelvic inflammatory disease
• Having uterine fibroids
• Having an adnexal cyst with risk of malignancy
• Being pregnant

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: September 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-01

Locations

TU (1)