Urogynecological and Sexual Functions After Vecchietti Operation

Mayer-Rokitansky-Kuster Syndrome Clinical Trial

Official title:

Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809819
• Other study ID #: 03/2019
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mayer-Rokitansky-Kuster Syndrome

Intervention

Procedure:
• laparoscopic Vecchietti vaginoplasty
Patients who underwent laparoscopic Vecchietti vaginoplasty

Diagnostic Test:
• FSFI questionnaire
Completion of FSFI questionnaire
• UDI-6 questionnaire
Completion of UDI-6 questionnaire
• IIQ-7 questionnaire
Completion of IIQ-7 questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sexual functions after Vecchietti operation	assessment of sexual functions after Vecchietti operation with the use of The Female Sexual Function Index (FSFI) questionnaire	8 years
Primary	Urinary incontinence after Vecchietti operation	assessment of Urinary incontinence after Vecchietti operation with the use of the Urinary Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7)	8 years