Materiovigilance After Urinary Incontinence or Prolapse Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

urinary incontinence, pelvic organ or rectal prolapse surgery: 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

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of severe complications — 10 years
  Grade III or more according to Clavien-Dindo classification

Trial sites (31)

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