NCT03052985: VIGI-MESH

Materiovigilance After Urinary Incontinence or Prolapse Surgery

Active, enrolled Last updated 21 September 2023

What this trial tests

trial testing urinary incontinence, pelvic organ or rectal prolapse surgery in Pelvic Organ Prolapse in 19,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 February 2017

Primary endpoint
1 May 2033

1 May 2033

Quick facts

Lead sponsor	Poitiers University Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	19,000
Start date	14 February 2017
Primary completion	1 May 2033
Estimated completion	1 May 2033
Sites	31 locations across France

Drugs / interventions tested

• urinary incontinence, pelvic organ or rectal prolapse surgery

Conditions studied

• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
• Rectal Prolapse — all drugs for Rectal Prolapse →
• Urinary Stress Incontinence — all drugs for Urinary Stress Incontinence →

Sponsor

Poitiers University Hospital

Who can join

18 and older, female only, with Pelvic Organ Prolapse or Rectal Prolapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Single-incision sling operations for urinary incontinence in women.
   Carter E, Johnson EE, Still M, Al-Assaf AS, et al · · 2023 · cited 13× · PMID 37888839 · DOI 10.1002/14651858.cd008709.pub4
2. Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse.
   De Gracia S, Fatton B, Cosson M, Campagne-Loiseau S, et al · · 2023 · cited 3× · PMID 36675397 · DOI 10.3390/jcm12020468