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Materiovigilance After Urinary Incontinence or Prolapse Surgery

NCT03052985 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 19000

Last updated 2023-09-21

No results posted yet for this 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.

Conditions

  • Pelvic Organ Prolapse
  • Rectal Prolapse
  • Urinary Stress Incontinence

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Agence Nationale de sécurité du Médicament

    collaborator OTHER

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Xavier FRITEL, PhD, MD · Poitiers University Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2033-05-01
Completion
2033-05-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052985 on ClinicalTrials.gov