Condition or disease | Intervention/treatment |
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Mayer-Rokitansky-Kuster Syndrome | Procedure: laparoscopic Vecchietti vaginoplasty Diagnostic Test: FSFI questionnaire Diagnostic Test: UDI-6 questionnaire Diagnostic Test: IIQ-7 questionnaire |
Study Type : | Observational |
Actual Enrollment : | 26 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty |
Actual Study Start Date : | January 1, 2011 |
Actual Primary Completion Date : | December 31, 2018 |
Actual Study Completion Date : | December 31, 2018 |
Group/Cohort | Intervention/treatment |
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Patients with MRKHS
Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
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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
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Control group
A control group of 13 age-matched, childless, sexually active women
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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
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Paweł Miotła, PhD | Medical University in Lublin |
Tracking Information | |||||
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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 |
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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 |
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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 |
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Study Groups/Cohorts |
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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. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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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 |
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IPD Sharing Statement |
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Responsible Party | Paweł Miotła, Medical University of Lublin | ||||
Study Sponsor | Medical University of Lublin | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Medical University of Lublin | ||||
Verification Date | January 2019 |