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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

Tracking Information
First Submitted Date January 16, 2019
First Posted Date January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date January 1, 2011
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
  • 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
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Urogynecological and Sexual Functions After Vecchietti Operation
Official Title Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty
Brief Summary The aim of this study was to establish the urogynecological and sexual functions after Vecchietti operation.
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
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Mayer-Rokitansky-Kuster Syndrome
Intervention
  • 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
Study Groups/Cohorts
  • Patients with MRKHS
    Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
    Interventions:
    • Procedure: laparoscopic Vecchietti vaginoplasty
    • Diagnostic Test: FSFI questionnaire
    • Diagnostic Test: UDI-6 questionnaire
    • Diagnostic Test: IIQ-7 questionnaire
  • Control group
    A control group of 13 age-matched, childless, sexually active women
    Interventions:
    • Diagnostic Test: FSFI questionnaire
    • Diagnostic Test: UDI-6 questionnaire
    • Diagnostic Test: IIQ-7 questionnaire
Publications * Adamiak-Godlewska A, Skorupska K, Rechberger T, Romanek-Piva K, Miotła P. Urogynecological and Sexual Functions after Vecchietti Reconstructive Surgery. Biomed Res Int. 2019 Feb 25;2019:2360185. doi: 10.1155/2019/2360185. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2019)
26
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03809819
Other Study ID Numbers 03/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Paweł Miotła, Medical University of Lublin
Study Sponsor Medical University of Lublin
Collaborators Not Provided
Investigators
Principal Investigator: Paweł Miotła, PhD Medical University in Lublin
PRS Account Medical University of Lublin
Verification Date January 2019