Materiovigilance After Urinary Incontinence or Prolapse Surgery
VIGI-MESH
Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
1 other identifier
observational
19,000
1 country
31
Brief Summary
Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
31 active sites
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
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedStudy Start
First participant enrolled
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2033
September 21, 2023
September 1, 2023
16.2 years
February 10, 2017
September 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of severe complications
Grade III or more according to Clavien-Dindo classification
10 years
Secondary Outcomes (5)
Time lapse of occurrence of severe complications
10 years
Surgical recovery for failure or recurrence
10 years
Health and perceived improvement
10 years
Health and perceived improvement
10 years
Health and perceived improvement
10 years
Interventions
The observatory is planned for following women after surgery for urinary incontinence, pelvic organ prolapse, or rectal prolapse whatever the type of surgery (by laparoscopy, laparotomy or vginal route) or the use of a mesh
Eligibility Criteria
Women operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory, aged 18 years old or more.
You may qualify if:
- Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
- years old or more.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Centre l'Avancée - Clinique Axium
Aix-en-Provence, 13090, France
C.H.U. d'Angers
Angers, 49900, France
CHRU de Besançon
Besançon, 25000, France
Centre Hospitalier de Béthune
Béthune, 62400, France
CHU de Bordeaux
Bordeaux, 33200, France
CHU Caen
Caen, 14033, France
Centre Hospitalier Camille Guérin
Châtellerault, 86106, France
Hôpital Antoine-Béclère
Clamart, 92140, France
Chu Estaing
Clermont-Ferrand, 630003, France
Centre Hospitalier de Dunkerque
Dunkirk, 59240, France
Polyclinique d'Hénin-Beaumont
Hénin-Beaumont, 62800, France
Hopital La Rochelle- Ré- Aunis
La Rochelle, 17000, France
CHU Lille
Lille, 59000, France
Hôpital St Vincent De Paul
Lille, 59000, France
CHU de Limoges
Limoges, 87000, France
Hospices Civils de Lyon
Lyon, 69000, France
Clinique BEAUSOLEIL
Montpellier, 34070, France
CHRU de NANCY
Nancy, 54511, France
CHU Nantes
Nantes, 44000, France
CHRU Carémeau
Nîmes, 30029, France
La Pitié-Salpêtrière
Paris, 75013, France
Hôpital Bichat
Paris, 75018, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
Centre briochin d'Urologie
Plérin, 21900, France
CHI Poissy-St-Germain
Poissy, 78300, France
CHU de Poitiers
Poitiers, 86000, France
CHU de Reims
Reims, 51000, France
CHU Strasbourg
Strasbourg, 37200, France
Hopital Foch
Suresnes, 92150, France
Clinique UROVAR
Toulon, 83000, France
CHU de Toulouse
Toulouse, 31000, France
Related Publications (1)
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PMID: 37888839DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier FRITEL, PhD, MD
Poitiers University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 14, 2017
Study Start
February 14, 2017
Primary Completion (Estimated)
May 1, 2033
Study Completion (Estimated)
May 1, 2033
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share