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Urogynecological and Sexual Functions After Vecchietti Operation

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ClinicalTrials.gov Identifier: NCT03809819
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Paweł Miotła, Medical University of Lublin

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

Condition or disease Intervention/treatment
Mayer-Rokitansky-Kuster Syndrome Procedure: laparoscopic Vecchietti vaginoplasty Diagnostic Test: FSFI questionnaire Diagnostic Test: UDI-6 questionnaire Diagnostic Test: IIQ-7 questionnaire

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 Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


Group/Cohort Intervention/treatment
Patients with MRKHS
Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
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

Control group
A control group of 13 age-matched, childless, sexually active women
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




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809819


Sponsors and Collaborators
Medical University of Lublin
Investigators
Principal Investigator: Paweł Miotła, PhD Medical University in Lublin

Responsible Party: Paweł Miotła, Clinical Professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03809819     History of Changes
Other Study ID Numbers: 03/2019
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paweł Miotła, Medical University of Lublin:
Laparoscopic Vecchietti vaginoplasty
sexual function
urinary incontinence

Additional relevant MeSH terms:
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases