RecruitingNAINTERVENTIONAL

LAparoscopic Preventive PRErectal Mesh

Urogenital prolapse is a common condition where organs like the bladder or womb can drop down, causing discomfort. Surgery can help, and a standard way to fix it uses a special mesh. Sometimes, an extra piece of mesh is placed to prevent new issues, but this can also lead to other problems like pain or bowel difficulties. This study wants to find out if using only one piece of mesh, placed at the front, is as good as or better than using two pieces of mesh (front and back). The aim is to reduce the chance of the prolapse coming back while also lowering the risk of side effects from the surgery itself. We are comparing these two approaches to see which offers the best results for women.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Lille

Enrolment target

834

Start

11 Sep 2019

Estimated completion

01 Dec 2026

Urogenital Prolapse

What is this study about?

This study is looking into a common health problem called urogenital prolapse. This happens when organs like your bladder or womb (uterus) drop down from their normal position. It's quite common, affecting many women, and can cause a lot of discomfort. For some women, surgery is a good option to help fix this issue and improve their quality of life. The surgery often involves using a special type of mesh to support the organs.

Currently, a common surgical method uses a mesh to support the front part of the vagina and the top of the vagina near the womb. Sometimes, doctors also place an extra piece of mesh at the back, near the rectum, to try and stop the prolapse from happening again in that area. However, putting in this extra mesh at the back might lead to other problems, such as a longer operation, pain, or issues with bowel movements.

This study wants to find out if it's really necessary to use this extra mesh at the back. We're comparing two ways of doing the surgery: one where only the front part is supported with mesh (called Single-Anterior-Mesh, or SAM) and another where both the front and back are supported (called Double-Mesh, or DM). By comparing these two approaches, we hope to understand which method is best for women, aiming to prevent the prolapse from returning while also keeping the risk of other surgery-related problems as low as possible.

Key takeaways

This study compares two ways of using surgical mesh for urogenital prolapse.
It aims to find out if using less mesh (one piece instead of two) can still be effective and reduce complications.
The study focuses on women with bladder or womb prolapse, not significant back wall prolapse.
Potential risks of the extra mesh include longer surgery, pain, and bowel issues.
Your participation could help improve future treatments for women with prolapse.

Who may be eligible?

This study is looking for women who are between 40 and 75 years old and have been diagnosed with urogenital prolapse where the bladder or womb has dropped down, but not a significant drop in the back wall of the vagina. To be included, your prolapse must be at a certain level that doctors measure.

You cannot join this study if you've had surgery before to fix prolapse. Also, if you have other types of prolapse that would need a different kind of surgery than what's being studied, you won't be able to take part. It's important that you don't plan to get pregnant in the future, as this study isn’t suitable for women who wish to have more children.

Finally, you need to have health insurance, be able to understand information in English (or French, as this study may be conducted in locations where French is spoken), and be able to give your consent to take part. You cannot participate if you are under legal protection or guardianship.

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 between 40 and 75 years old?
Do you have a diagnosis of bladder or womb prolapse?
Have you NOT had surgery for prolapse before?
Are you NOT planning to get pregnant in the future?
Are you able to speak and understand English (or French)?
Are you able to give your consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo surgery for your prolapse, which will involve either a single piece of mesh at the front or two pieces of mesh (front and back). The specific procedure will be decided by the study team. You will have follow-up appointments after your surgery to check on your recovery and how the mesh is working. These appointments will involve discussions with the medical team and possibly examinations. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer you a chance to receive one of the standard surgical treatments for prolapse, potentially improving your symptoms. However, like any surgery, there are potential risks, including infection, pain, bleeding, and specific complications related to the mesh such as damage to surrounding organs or discomfort. The study aims to understand if one approach has fewer side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

Hopital Estaing
Verified postcode
Clermont-Ferrand, France· Recruiting
Ch Dunkerque
Verified postcode
Dunkirk, France· Recruiting
Hopital Saint-Louis - La Rochelle
Verified postcode
La Rochelle, France· Recruiting
Clinique Du Pre
Verified postcode
Le Mans, France· Recruiting
Hop Jeanne de Flandre Chu Lille
Verified postcode
Lille, France· Recruiting
Hopital Saint Vincent - Saint Antoine
Verified postcode
Lille, France· Recruiting
Chu de Nice Hopital de L'Archet
Verified postcode
Nice, France· Recruiting
Chu Nimes - Nimes
Verified postcode
Nîmes, France· Recruiting
Chi Poissy St Germain Site de Poissy
Verified postcode
Poissy, France· Recruiting

Common questions

What is urogenital prolapse?

It's when organs like your bladder or womb drop down from their normal position, often causing discomfort or problems with bladder or bowel function.

What is mesh in this type of surgery?

Mesh is a special material used to support the organs that have dropped down, helping to hold them in their correct place.

What are the two types of surgery being compared?

We are comparing using one piece of mesh to support the front (Single-Anterior-Mesh) versus using two pieces of mesh, one at the front and one at the back (Double-Mesh).

Why is this study important?

It helps us find out which surgical method is safer and more effective for women, aiming to prevent the prolapse from coming back while reducing side effects.

Will I know which type of mesh I receive?

The study aims to compare the two methods fairly. The specific details of how you will be informed about your treatment will be discussed with you by the study team.

How to find out more

Jean-Philippe LUCOT, MD,PhD

lucot.jean-philippe@ghicl.net (0)3 21 45 62 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.