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Urogynecological and Sexual Functions After Vecchietti Operation

NCT03809819 — Completed, 26 participants, Medical University of Lublin
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Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty

RegistryNCT03809819
StatusCompleted
Study typeObservational
Enrollment26 (Actual)
SponsorMedical University of Lublin (Other)
ConditionsMayer-Rokitansky-Kuster Syndrome
Interventionslaparoscopic Vecchietti vaginoplasty, FSFI questionnaire, UDI-6 questionnaire, IIQ-7 questionnaire (Procedure, diagnostic test)
Datesstart 2011-01-01, primary completion 2018-12-31, completion 2018-12-31, first posted 2019-01-18, last updated 2019-01-18

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients with MRKHSProcedure: laparoscopic Vecchietti vaginoplasty; Diagnostic Test: FSFI questionnaire; Diagnostic Test: UDI-6 questionnaire; Diagnostic Test: IIQ-7 questionnaireThirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
Control groupDiagnostic Test: FSFI questionnaire; Diagnostic Test: UDI-6 questionnaire; Diagnostic Test: IIQ-7 questionnaireA control group of 13 age-matched, childless, sexually active women
  • 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

+Outcome measures

Primary outcomes

  • 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)

+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

+Publications

  • Results publication: Adamiak-Godlewska A, Skorupska K, Rechberger T, Romanek-Piva K, Miotla P. Urogynecological and Sexual Functions after Vecchietti Reconstructive Surgery. Biomed Res Int. 2019 Feb 25;2019:2360185. doi: 10.1155/2019/2360185. eCollection 2019. PMID 30931323

+Investigators

  • Paweł Miotła, PhD, Principal investigator, Medical University in Lublin

My Notes