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Completed

NCT Number: NCT03809819

Urogynecological and Sexual Functions After Vecchietti Operation

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

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Key information

Conditions

Mayer-Rokitansky-Kuster Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mullerian aplasia Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic Vecchietti vaginoplasty

Procedure

Patients who underwent laparoscopic Vecchietti vaginoplasty

FSFI questionnaire

Diagnostic Test

Completion of FSFI questionnaire

UDI-6 questionnaire

Diagnostic Test

Completion of UDI-6 questionnaire

IIQ-7 questionnaire

Diagnostic Test

Completion of IIQ-7 questionnaire

Primary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2019
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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