Mayer-Rokitansky-Kuster SyndromeNCT03809819
Urogynecological and Sexual Functions After Vecchietti Operation
An observational study of Mayer-Rokitansky-Kuster Syndrome, run by Medical University of Lublin.
Trial summary
The aim of this study was to establish the urogynecological and sexual functions after Vecchietti operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mayer-Rokitansky-Kuster Syndrome
- What is being tested?
- laparoscopic Vecchietti vaginoplasty, FSFI questionnaire and UDI-6 questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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
Who may be able to join
- patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
- control group of 13 age-matched, childless, sexually active women
Who cannot join
- unability to understand informed consent
About this study
Official title: Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty
The aim of this study was to establish the urogynecological and sexual functions after Vecchietti operation.
Read the 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.
- Conditions
- Mayer-Rokitansky-Kuster Syndrome
- Being tested
- laparoscopic Vecchietti vaginoplasty, FSFI questionnaire, UDI-6 questionnaire, IIQ-7 questionnaire
- Keywords
- Laparoscopic Vecchietti vaginoplasty, sexual function, urinary incontinence
- Medical subject headings
- Mullerian aplasia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic Vecchietti vaginoplastyProcedure or surgery
Patients who underwent laparoscopic Vecchietti vaginoplasty
FSFI questionnaireDiagnostic test
Completion of FSFI questionnaire
UDI-6 questionnaireDiagnostic test
Completion of UDI-6 questionnaire
IIQ-7 questionnaireDiagnostic test
Completion of IIQ-7 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with MRKHS | Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty Receives: 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 Receives: Diagnostic Test: FSFI questionnaire; Diagnostic Test: UDI-6 questionnaire; Diagnostic Test: IIQ-7 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual functions after Vecchietti operation
assessment of sexual functions after Vecchietti operation with the use of The Female Sexual Function Index (FSFI) questionnaire
Measured: 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)
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Jan 2011
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mayer-Rokitansky-Kuster SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Miotła, Medical University of Lublin
- Investigators
- Paweł Miotła, PhD, Principal investigator, Medical University in Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809819
- Sponsor's protocol ID
- 03/2019
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30931323
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urogynecological and Sexual Functions After Laparoscopic Vecchietti Vaginoplasty
- ClinicalTrials.gov ID
- NCT03809819
- Acronym / sponsor ID
- 03/2019
- Conditions
- Mayer-Rokitansky-Kuster Syndrome
- Keywords
- Laparoscopic Vecchietti vaginoplasty, sexual function, urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MRKHS | – | Procedure: laparoscopic Vecchietti vaginoplasty, Diagnostic Test: FSFI questionnaire, Diagnostic Test: UDI-6 questionnaire, Diagnostic Test: IIQ-7 questionnaireThirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty |
| Control group | – | Diagnostic Test: FSFI questionnaire, Diagnostic Test: UDI-6 questionnaire, Diagnostic Test: IIQ-7 questionnaireA control group of 13 age-matched, childless, sexually active women |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
- control group of 13 age-matched, childless, sexually active women
Key exclusion criteria (1 listed)
- unability to understand informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic Vecchietti vaginoplastyPatients who underwent laparoscopic Vecchietti vaginoplasty | Procedure or surgery | Patients with MRKHS |
| FSFI questionnaireCompletion of FSFI questionnaire | Diagnostic test | Control group, Patients with MRKHS |
| UDI-6 questionnaireCompletion of UDI-6 questionnaire | Diagnostic test | Control group, Patients with MRKHS |
| IIQ-7 questionnaireCompletion of IIQ-7 questionnaire | Diagnostic test | Control group, Patients with MRKHS |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Derived from this study: PubMed 30931323Adamiak-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Miotła, PhD principal investigator
Medical University in Lublin
Questions about this trial
What is this clinical trial studying?
An observational study of Mayer-Rokitansky-Kuster Syndrome, run by Medical University of Lublin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual functions after Vecchietti operation (time frame: 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.