Vaginal Native Tissues Repair for Pelvic Organ Prolapse
This study is about helping women who have a common condition where their bladder or other pelvic organs drop down, known as 'prolapse'. Many women over 50 experience this, and it can be quite upsetting. We're comparing two types of surgery that use a woman's own tissues to fix the problem: a standard operation called 'anterior colporrhaphy' and a different method called 'vaginal patch plastron'. Both are already used. The main goal is to find out which surgery works best at fixing the prolapse and making women feel better, both physically and emotionally, one year after the operation. We'll be looking closely at how effective each surgery is.
At a glance
What is this study about?
Pelvic organ prolapse is a common condition where the organs in a woman's pelvis, like the bladder, womb, or bowel, can drop down and press into the vagina. This can cause uncomfortable symptoms such as a feeling of heaviness or a bulge, and can really affect a woman's daily life and confidence. It's especially common for women over 50. Many women choose to have surgery to help fix this.
Over the years, doctors have found that using a woman's own tissues for these repairs is generally safer than using synthetic mesh, which has caused problems for some women. Therefore, this study focuses on two surgical techniques that use your body's natural tissues. One is a well-established operation called 'anterior colporrhaphy', and the other is a procedure called 'vaginal patch plastron'. Both are currently used by surgeons, and we know they can be effective.
The main aim of this study is to see which of these two surgeries works better for women with a dropped bladder (this is the most common type of prolapse). We want to compare their effectiveness one year after surgery. We'll be looking at whether the prolapse has been corrected physically and if women feel better emotionally and functionally. We believe the 'vaginal patch plastron' might be more effective because it addresses the prolapse in a slightly different way, providing support for the bladder in more than one area.
Key takeaways
- Compares two existing surgeries for dropped bladder (prolapse).
- Uses your own body's tissues for repair, not mesh.
- Aims to find out which surgery works best after one year.
- Participation involves surgery and follow-up for about one year.
- Open to women aged 50 or over with symptomatic bladder prolapse.
Who may be eligible?
This study is looking for women aged 50 or over who are experiencing symptoms from a dropped bladder (front vaginal wall prolapse). You would likely be a good fit if you feel a bulge or something falling out in your vaginal area.
To join, you need to be able to understand the study and agree to take part, and be well enough to have surgery. You also need to have social insurance in France, as this study is taking place there.
You wouldn't be able to join if you need surgery for other muscle issues in your pelvis, or if you've had surgery for a dropped bladder before. Also, if you have certain types of gynaecological cancer, are pregnant, planning to become pregnant, or breastfeeding, this study would not be suitable for you.
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 50 years old or older?
- Do you feel a bulge or something falling out in your vagina?
- Have you NOT had surgery for a dropped bladder before?
- Are you NOT pregnant and not planning a pregnancy soon?
- Are you able to agree to take part after understanding the study information?
What does participation involve?
If you decide to take part in this study, you would undergo one of the two types of surgery mentioned – either the anterior colporrhaphy or the vaginal patch plastron. The type of surgery you receive will be decided randomly, like flipping a coin. You will have follow-up appointments over one year to check how you are recovering and how effective the surgery has been. These appointments will involve checking your physical condition and asking you about your symptoms and how you feel. We don't expect you to take any extra medication for this study. The total duration of your active participation will be about one year.
Potential risks and benefits
Locations (9)
- CHU de BordeauxVerified postcodeBordeaux, France· Recruiting
- CH de BriveVerified postcodeBrive-la-Gaillarde, France· Recruiting
- CHU de Clermont FerrandVerified postcodeClermont-Ferrand, France· Recruiting
- CH de GueretVerified postcodeGuéret, France· Recruiting
- CHU de LimogesVerified postcodeLimoges, France· Recruiting
- CHU de Saint-EtienneVerified postcodeSaint-Etienne, France· Recruiting
- CHU de Toulouse - Paule de ViguierVerified postcodeToulouse, France· Recruiting
- CHU de Toulouse - RangueilVerified postcodeToulouse, France· Recruiting
- CH de TulleVerified postcodeTulle, France· Recruiting
Common questions
What is 'pelvic organ prolapse'?
It's when organs in your pelvis, like your bladder, drop down and press into your vagina, causing uncomfortable feelings or a bulge.
What kind of surgery will I have?
You'll have one of two types of surgery that use your own body tissues to support your bladder: either anterior colporrhaphy or vaginal patch plastron. The specific type will be chosen at random.
How long will I be involved in the study?
Your involvement will last for about one year, including your surgery and follow-up appointments.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.
Who is paying for this study?
The information provided does not specify the funding source for this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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