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Materiovigilance After Urinary Incontinence or Prolapse Surgery (VIGI-MESH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052985
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Agence Nationale de sécurité du Médicament
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Rectal Prolapse Urinary Stress Incontinence Procedure: urinary incontinence, pelvic organ or rectal prolapse surgery

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : February 14, 2022
Estimated Study Completion Date : February 14, 2032

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Incidence of severe complications [ Time Frame: 10 years ]
    Grade III or more according to Clavien-Dindo classification


Secondary Outcome Measures :
  1. Time lapse of occurrence of severe complications [ Time Frame: 10 years ]
  2. Surgical recovery for failure or recurrence [ Time Frame: 10 years ]
    Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence

  3. Health and perceived improvement [ Time Frame: 10 years ]
    Scale OMS/ ECOG Eastern Cooperative Oncology Groupone covers six values, from 0 to 5, where 0 represents a good state of health and 5 the death.

  4. Health and perceived improvement [ Time Frame: 10 years ]

    EQ5D is a standardised measure of health status developed

    Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems :

    • Level 1 : indicating no problem
    • Level 2 : indicating slight problems
    • Level 3 : indicating moderate problems
    • Level 4 : indicating severe problems
    • Level 5 : indicating extreme problems

  5. Health and perceived improvement [ Time Frame: 10 years ]
    PGI-I, Patient Global Impression of Improvement, is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052985


Contacts
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Contact: Lucie Merlet, CRA +33 (0)5.49.44.30.59 lucie.merlet@chu-poitiers.fr

Locations
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Sponsors and Collaborators
Poitiers University Hospital
Agence Nationale de sécurité du Médicament
Investigators
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Principal Investigator: Xavier FRITEL, PhD, MD Poitiers University Hospital
Additional Information:

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03052985    
Other Study ID Numbers: 2016-A01868-43
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poitiers University Hospital:
medical devices (meshes)
surgery
Additional relevant MeSH terms:
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Rectal Prolapse
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases