Urogynecological and Sexual Functions After Vecchietti Operation

January 17, 2019 updated by: Paweł Miotła, Medical University of Lublin

Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

26

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 years
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)
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Investigators

  • Principal Investigator: Paweł Miotła, PhD, Medical University in Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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