NCT03809819

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

8 years

First QC Date

January 16, 2019

Last Update Submit

January 17, 2019

Conditions

Mayer-Rokitansky-Kuster Syndrome

Keywords

Laparoscopic Vecchietti vaginoplastysexual functionurinary incontinence

Outcome Measures

Primary Outcomes (2)

  • sexual functions after Vecchietti operation

    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

    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

Study Arms (2)

Patients with MRKHS

Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty

Procedure: laparoscopic Vecchietti vaginoplastyDiagnostic Test: FSFI questionnaireDiagnostic Test: UDI-6 questionnaireDiagnostic Test: IIQ-7 questionnaire

Control group

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

Diagnostic Test: FSFI questionnaireDiagnostic Test: UDI-6 questionnaireDiagnostic Test: IIQ-7 questionnaire

Interventions

laparoscopic Vecchietti vaginoplastyPROCEDURE

Patients who underwent laparoscopic Vecchietti vaginoplasty

Patients with MRKHS
FSFI questionnaireDIAGNOSTIC_TEST

Completion of FSFI questionnaire

Control groupPatients with MRKHS
UDI-6 questionnaireDIAGNOSTIC_TEST

Completion of UDI-6 questionnaire

Control groupPatients with MRKHS
IIQ-7 questionnaireDIAGNOSTIC_TEST

Completion of IIQ-7 questionnaire

Control groupPatients with MRKHS

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
  • control group of 13 age-matched, childless, sexually active women

You may not qualify if:

  • unability to understand informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 30931323DERIVED

MeSH Terms

Conditions

Mullerian aplasiaUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paweł Miotła, PhD

    Medical University in Lublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 18, 2019

Study Start

January 1, 2011

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share