Active not recruitingOBSERVATIONAL

Materiovigilance After Urinary Incontinence or Prolapse Surgery

This study is an important project looking into the safety of operations for women who have bladder weakness (urinary incontinence) or a condition called prolapse, where organs in the pelvis drop down. Doctors will be checking for any severe problems that might occur during or after these surgeries. Special attention will be paid to procedures where internal devices, known as meshes, are used, as these can sometimes lead to serious complications. The main aim is to understand how often these severe complications happen and what might cause them. By gathering this information, researchers hope to make these operations safer and improve patient care in the future. The study will also ask women about their health and how happy they are with their surgery.

At a glance

Status

Active not recruiting

Sponsor

Poitiers University Hospital

Enrolment target

19,000

Start

14 Feb 2017

Estimated completion

01 May 2033

Pelvic Organ Prolapse Rectal Prolapse Urinary Stress Incontinence

What is this study about?

This study, called an "observatory," is carefully watching what happens to women after they have surgery for common conditions like bladder weakness (urinary incontinence) or pelvic organ prolapse. Prolapse is when organs in the pelvis, like the bladder, womb, or bowel, slip out of their normal position. These surgeries often help improve quality of life, but sometimes serious problems can occur.

Doctors are particularly interested in understanding risks linked to surgical meshes. These are special implants that some surgeons use to support weakened tissues during these operations. While meshes can be very helpful, they have also been linked to some severe complications. This study aims to gather detailed information about how often significant problems, either during or after surgery, happen so that doctors can better understand these risks.

By carefully observing many women over time, this study hopes to identify factors that might increase the chance of severe complications. This includes looking at different types of surgery (with or without mesh), the type of mesh used, and even how experienced the surgeon is. The ultimate goal is to use this information to make these surgeries safer, improve surgical techniques, and help women and their doctors make more informed decisions about treatment.

Key takeaways

This study observes outcomes after surgery for bladder weakness or prolapse.
It focuses on understanding the risks of severe complications, especially with surgical mesh.
It aims to improve patient safety and care.
Participation involves sharing medical information and completing questionnaires.
You won't receive new treatments through the study, nor will it affect your care.
Your data helps future patients.

Who may be eligible?

You might be able to take part in this study if you are a woman aged 18 or older.

To be included, you must have recently had surgery for bladder weakness (urinary incontinence) or for pelvic organ prolapse (when organs like the bladder or womb have dropped) or rectal prolapse (when part of the bowel drops) at one of the hospitals taking part in this study.

The study is only for women who have had one of these specific operations at a participating centre, and you must be at least 18 years old.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Have you recently had surgery for bladder weakness, pelvic organ prolapse, or rectal prolapse?
Was your surgery performed at a hospital taking part in this study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the doctors and nurses will follow your health after your surgery for bladder weakness or prolapse. This isn't a study where you try a new treatment; instead, it's about observing how you recover over time after your normal operation. They will be looking for any severe problems that might occur during or after your surgery.

You won't need to take any new medication specifically for the study. Instead, information about your recovery and any complications will be collected from your medical records. You will also be asked to fill out some questionnaires about your health, how you feel, and your satisfaction with the surgery. This will help the researchers understand your experience and how your health has changed. The total duration of your involvement will depend on how long the doctors follow up on your progress, which could be for a few years after your surgery.

Potential risks and benefits

Taking part in this study does not involve any direct medical intervention beyond your planned surgery. The main benefit is that your information will help doctors understand more about the safety and effectiveness of these surgeries, potentially leading to better care for other women in the future. There are no direct medical benefits to you personally, as it's an observational study, not a treatment trial. The main risk is the time and effort involved in completing the questionnaires. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (31)

Centre l'Avancée - Clinique Axium
Verified postcode
Aix-en-Provence, France
C.H.U. d'Angers
Verified postcode
Angers, France
CHRU de Besançon
Verified postcode
Besançon, France
Centre Hospitalier de Béthune
Verified postcode
Béthune, France
CHU de Bordeaux
Verified postcode
Bordeaux, France
CHU Caen
Verified postcode
Caen, France
Centre Hospitalier Camille Guérin
Verified postcode
Châtellerault, France
Hôpital Antoine-Béclère
Verified postcode
Clamart, France
Chu Estaing
Verified postcode
Clermont-Ferrand, France
Centre Hospitalier de Dunkerque
Verified postcode
Dunkirk, France
Polyclinique d'Hénin-Beaumont
Verified postcode
Hénin-Beaumont, France
Hopital La Rochelle- Ré- Aunis
Verified postcode
La Rochelle, France

Common questions

What is the main goal of this study?

The study aims to understand how often serious problems happen during or after surgery for bladder weakness or prolapse in women, especially when surgical mesh is used.

What is 'materiovigilance'?

Materiovigilance means carefully watching how well medical devices (like surgical meshes) work and if they cause any problems after they've been used in patients.

Will I receive any new treatment as part of this study?

No, this is an observational study. You will receive your standard surgery, and researchers will simply gather information about your recovery and experience.

What is a 'severe complication'?

In this study, a severe complication means a problem that is serious enough to need further treatment, like another operation or a special procedure, or one that has a significant impact on your health.

How long will I be involved?

The study will collect information for up to several years after your surgery to see how your health changes over time.