Urogynecological and Sexual Functions After Vecchietti Operation

Overview

The aim of this study was to establish the urogynecological and sexual functions after Vecchietti operation.

Full Title of Study: “Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2018

Detailed Description

Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty were included. A control group of 13 age-matched, childless, sexually active women were examined during the same period. All patients underwent the basic evaluation of anatomical outcomes. Sexual outcomes were established by polish validated FSFI questionnaire. Continence status was assessed by polish validated UDI-6 and IIQ-7 questionnaires. The UDI-6 is subdivided in three domains: stress incontinence, irritative and obstructive discomfort. The IIQ-7 measures the implications of urinary incontinence for normal daily functioning.

Interventions

  • Procedure: laparoscopic Vecchietti vaginoplasty
    • Patients who underwent laparoscopic Vecchietti vaginoplasty
  • Diagnostic Test: FSFI questionnaire
    • Completion of FSFI questionnaire
  • Diagnostic Test: UDI-6 questionnaire
    • Completion of UDI-6 questionnaire
  • Diagnostic Test: IIQ-7 questionnaire
    • Completion of IIQ-7 questionnaire

Arms, Groups and Cohorts

  • Patients with MRKHS
    • Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
  • Control group
    • A control group of 13 age-matched, childless, sexually active women

Clinical Trial Outcome Measures

Primary Measures

  • sexual functions after Vecchietti operation
    • Time Frame: 8 years
    • assessment of sexual functions after Vecchietti operation with the use of The Female Sexual Function Index (FSFI) questionnaire
  • Urinary incontinence after Vecchietti operation
    • Time Frame: 8 years
    • assessment of Urinary incontinence after Vecchietti operation with the use of the Urinary Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7)

Participating in This Clinical Trial

Inclusion Criteria

  • patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty – control group of 13 age-matched, childless, sexually active women Exclusion Criteria:

  • unability to understand informed consent

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Medical University of Lublin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paweł Miotła, Clinical Professor – Medical University of Lublin
  • Overall Official(s)
    • Paweł Miotła, PhD, Principal Investigator, Medical University in Lublin

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.