Pelvic Organ ProlapseVIGI-MESHNCT03052985
Materiovigilance After Urinary Incontinence or Prolapse Surgery
An observational study of Pelvic Organ Prolapse and Rectal Prolapse, run by Poitiers University Hospital at 31 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Rectal Prolapse, Urinary Stress Incontinence
- What is being tested?
- urinary incontinence, pelvic organ or rectal prolapse surgery
- Type of treatment
- Surgery or procedure
- How many people
- 19,000 participants
- Where
- 31 sitesFrance
- Study dates
- 14 Feb 2017to 1 May 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
- 18 years old or more.
Who cannot join
None listed.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Centre l'Avancée - Clinique Axium
Aix-en-Provence, 13090
C.H.U. d'Angers
Angers, 49900
CHRU de Besançon
Besançon, 25000
Centre Hospitalier de Béthune
Béthune, 62400
CHU de Bordeaux
Bordeaux, 33200
CHU Caen
Caen, 14033
Centre Hospitalier Camille Guérin
Châtellerault, 86106
Hôpital Antoine-Béclère
Clamart, 92140
Chu Estaing
Clermont-Ferrand, 630003
Centre Hospitalier de Dunkerque
Dunkirk, 59240
Polyclinique d'Hénin-Beaumont
Hénin-Beaumont, 62800
Hopital La Rochelle- Ré- Aunis
La Rochelle, 17000
CHU Lille
Lille, 59000
Hôpital St Vincent De Paul
Lille, 59000
CHU de Limoges
Limoges, 87000
Hospices Civils de Lyon
Lyon, 69000
Clinique BEAUSOLEIL
Montpellier, 34070
CHRU de NANCY
Nancy, 54511
CHU Nantes
Nantes, 44000
CHRU Carémeau
Nîmes, 30029
La Pitié-Salpêtrière
Paris, 75013
Hôpital Bichat
Paris, 75018
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris
Centre briochin d'Urologie
Plérin, 21900
CHI Poissy-St-Germain
Poissy, 78300
CHU de Poitiers
Poitiers, 86000
CHU de Reims
Reims, 51000
CHU Strasbourg
Strasbourg, 37200
Hopital Foch
Suresnes, 92150
Clinique UROVAR
Toulon, 83000
CHU de Toulouse
Toulouse, 31000
About this study
Official title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
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.
Read the detailed description
RATIONAL Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
MAIN OBJECTIVE Estimate the incidence of severe complications during or after surgery of urinary incontinence or pelvic organ prolapse in adult women depending on the type of surgery performed.
SECONDARY OBJECTIVES Estimate the incidence of severe complications after urinary incontinence or prolapse surgery as a function of time since surgery.
Compare the incidence rates of severe complications considering the type of procedure (with or without mesh, vaginal or laparoscopic, etc.), comorbidities, mesh type, surgeon experience, and surgical volume centre.
Report the health and satisfaction of operated women. Estimate the risk of revision surgery for failure or recurrence.
MAIN OUTCOME Per- and post-operative complications (less than 12 months after surgery), or late (after 12 months) severe (grade III or higher according to the Clavien-Dindo classification)
OTHER OUTCOMES Time lapse of occurrence of severe complications Surgical recovery for failure or recurrence Health and perceived improvement (OMS, EQ5D, an PGI-I questionnaires)
DESIGN Prospective multicentre cohort allowing the constitution and analysis of an observatory off surgery for genital prolapse, rectal prolapse and urinary stress incontinence in women.
INCLUSION CRITERIA
- Operated for urinary incontinence, genital prolapse, or rectal prolapse in one of the centres participating in the observatory
- 18 years old or more.
SUBJECTS NUMBER Estimated at 3000 per year during 5 years in 18 participating centres
STUDY LENGTH Duration of the inclusion period: 2 years with the initial grant from ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, French Medicines and Healthcare Products Regulatory Agency), after new funding by ANSM 5 years of inclusion in total.
Duration of participation of subjects: 2 years with grant from ANSM, after the new funding by ANSM 10 years.
Total duration of the study: 3 years with the grant from ANSM, 15 years with the new funding.
ANALYSIS PLANNED The one-year analysis will be based on multivariate logistic regression analysis (considering confounding factors). The 10-year (or intermediate-term) analysis will use survival analysis methods to account for delays in complications: Kaplan-Meier curves; Model of Cox proportional hazards.
PERSPECTIVES The observatory should make it possible to precise the tolerance and the short- and long-term consequences of the use of these implantable devices (meshes) in pelvic organ prolapse or incontinence surgery in women and to specify the risk factors for severe complications.
The observatory will enable to make comparisons between the different types of meshes and different surgical procedures, and to identify those that may present problems.
Clinical practice recommendations may be issued as well as standards for marketing.
- Being tested
- urinary incontinence, pelvic organ or rectal prolapse surgery
- Keywords
- medical devices (meshes), surgery
- Medical subject headings
- Pelvic Organ Prolapse, Rectal Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary incontinence, pelvic organ or rectal prolapse surgeryProcedure or 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe complications
Grade III or more according to Clavien-Dindo classification
Measured: 10 years
Secondary outcomes (5)
Time lapse of occurrence of severe complications
Measured: 10 years
Surgical recovery for failure or recurrence
Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence
Measured: 10 years
Health and perceived improvement
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.
Measured: 10 years
Health and perceived improvement
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
Measured: 10 years
Health and perceived improvement
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start14 Feb 2017
- Primary completion1 May 2033 (estimated)
- Study completion1 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament
- Responsible party
- Sponsor
- Investigators
- Xavier FRITEL, PhD, MD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052985
- Sponsor's protocol ID
- 2016-A01868-43
- Acronym
- VIGI-MESH
- Status last verified
- Sep 2023
- First submitted
- 10 Feb 2017
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
- ClinicalTrials.gov ID
- NCT03052985
- Acronym / sponsor ID
- VIGI-MESH / 2016-A01868-43
- Keywords
- medical devices (meshes), surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 19,000 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 May 2033 (estimated)
- Study completion
- 1 May 2033 (estimated)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONAL Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.
MAIN OBJECTIVE Estimate the incidence of severe complications during or after surgery of urinary incontinence or pelvic organ prolapse in adult women depending on the type of surgery performed.
SECONDARY OBJECTIVES Estimate the incidence of severe complications after urinary incontinence or prolapse surgery as a function of time since surgery.
Compare the incidence rates of severe complications considering the type of procedure (with or without mesh, vaginal or laparoscopic, etc.), comorbidities, mesh type, surgeon experience, and surgical volume centre.
Report the health and satisfaction of operated women. Estimate the risk of revision surgery for failure or recurrence.
MAIN OUTCOME Per- and post-operative complications (less than 12 months after surgery), or late (after 12 months) severe (grade III or higher according to the Clavien-Dindo classification)
OTHER OUTCOMES Time lapse of occurrence of severe complications Surgical recovery for failure or recurrence Health and perceived improvement (OMS, EQ5D, an PGI-I questionnaires)
DESIGN Prospective multicentre cohort allowing the constitution and analysis of an observatory off surgery for genital prolapse, rectal prolapse and urinary stress incontinence in women.
INCLUSION CRITERIA
- Operated for urinary incontinence, genital prolapse, or rectal prolapse in one of the centres participating in the observatory
- 18 years old or more.
SUBJECTS NUMBER Estimated at 3000 per year during 5 years in 18 participating centres
STUDY LENGTH Duration of the inclusion period: 2 years with the initial grant from ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, French Medicines and Healthcare Products Regulatory Agency), after new funding by ANSM 5 years of inclusion in total.
Duration of participation of subjects: 2 years with grant from ANSM, after the new funding by ANSM 10 years.
Total duration of the study: 3 years with the grant from ANSM, 15 years with the new funding.
ANALYSIS PLANNED The one-year analysis will be based on multivariate logistic regression analysis (considering confounding factors). The 10-year (or intermediate-term) analysis will use survival analysis methods to account for delays in complications: Kaplan-Meier curves; Model of Cox proportional hazards.
PERSPECTIVES The observatory should make it possible to precise the tolerance and the short- and long-term consequences of the use of these implantable devices (meshes) in pelvic organ prolapse or incontinence surgery in women and to specify the risk factors for severe complications.
The observatory will enable to make comparisons between the different types of meshes and different surgical procedures, and to identify those that may present problems.
Clinical practice recommendations may be issued as well as standards for marketing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
- 18 years old or more.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urinary incontinence, pelvic organ or rectal prolapse surgeryThe 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 | Procedure or surgery | – |
Primary outcome
Incidence of severe complications
Time frame: 10 years
Grade III or more according to Clavien-Dindo classification
5 secondary outcomes
Time lapse of occurrence of severe complications
Time frame: 10 years
Surgical recovery for failure or recurrence
Time frame: 10 years
Health and perceived improvement
Time frame: 10 years
Health and perceived improvement
Time frame: 10 years
Health and perceived improvement
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 37888839Carter 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.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier FRITEL, PhD, MD principal investigator
Poitiers University Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Rectal Prolapse, run by Poitiers University Hospital at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe complications (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.