Urogynecological and Sexual Functions After Vecchietti Operation

NCT ID: NCT03809819

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Mayer-Rokitansky-Kuster Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with MRKHS

Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty

laparoscopic Vecchietti vaginoplasty

Intervention Type PROCEDURE

Patients who underwent laparoscopic Vecchietti vaginoplasty

FSFI questionnaire

Intervention Type DIAGNOSTIC_TEST

Completion of FSFI questionnaire

UDI-6 questionnaire

Intervention Type DIAGNOSTIC_TEST

Completion of UDI-6 questionnaire

IIQ-7 questionnaire

Intervention Type DIAGNOSTIC_TEST

Completion of IIQ-7 questionnaire

Control group

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

FSFI questionnaire

Intervention Type DIAGNOSTIC_TEST

Completion of FSFI questionnaire

UDI-6 questionnaire

Intervention Type DIAGNOSTIC_TEST

Completion of UDI-6 questionnaire

IIQ-7 questionnaire

Intervention Type DIAGNOSTIC_TEST

Completion of IIQ-7 questionnaire

Interventions

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laparoscopic Vecchietti vaginoplasty

Patients who underwent laparoscopic Vecchietti vaginoplasty

Intervention Type PROCEDURE

FSFI questionnaire

Completion of FSFI questionnaire

Intervention Type DIAGNOSTIC_TEST

UDI-6 questionnaire

Completion of UDI-6 questionnaire

Intervention Type DIAGNOSTIC_TEST

IIQ-7 questionnaire

Completion of IIQ-7 questionnaire

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Paweł Miotła

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paweł Miotła, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University in Lublin

References

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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.

Reference Type DERIVED
PMID: 30931323 (View on PubMed)

Other Identifiers

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03/2019

Identifier Type: -

Identifier Source: org_study_id

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