Urogynecological and Sexual Functions After Vecchietti Operation

Completed

• Conditions: Mayer-Rokitansky-Kuster Syndrome
• Interventions: Diagnostic Test: FSFI questionnaire; Procedure: laparoscopic Vecchietti vaginoplasty; Diagnostic Test: UDI-6 questionnaire; Diagnostic Test: IIQ-7 questionnaire

• Registration Number: NCT03809819
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-18
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	FSFI questionnaire	A control group of 13 age-matched, childless, sexually active women
Patients with MRKHS	IIQ-7 questionnaire	Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
Control group	UDI-6 questionnaire	A control group of 13 age-matched, childless, sexually active women
Patients with MRKHS	laparoscopic Vecchietti vaginoplasty	Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
Patients with MRKHS	FSFI questionnaire	Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
Patients with MRKHS	UDI-6 questionnaire	Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
Control group	IIQ-7 questionnaire	A control group of 13 age-matched, childless, sexually active women

Primary Outcome Measures

Name	Time	Method
sexual functions after Vecchietti operation	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	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)