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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2023 |
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Main ID: |
NCT03052985 |
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Date of registration:
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10/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Materiovigilance After Urinary Incontinence or Prolapse Surgery
VIGI-MESH |
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Scientific title:
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Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women. |
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Date of first enrolment:
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February 14, 2017 |
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Target sample size:
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19000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03052985 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Xavier FRITEL, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Poitiers University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of
the centres participating in the observatory
- 18 years old or more.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urinary Stress Incontinence
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Pelvic Organ Prolapse
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Rectal Prolapse
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Intervention(s)
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Procedure: urinary incontinence, pelvic organ or rectal prolapse surgery
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Primary Outcome(s)
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Incidence of severe complications
[Time Frame: 10 years]
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Secondary Outcome(s)
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Surgical recovery for failure or recurrence
[Time Frame: 10 years]
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Health and perceived improvement
[Time Frame: 10 years]
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Time lapse of occurrence of severe complications
[Time Frame: 10 years]
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Secondary ID(s)
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2016-A01868-43
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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