Not yet recruitingNAINTERVENTIONAL

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)

This research is investigating a new Y-shaped mesh called ProGYNious, designed for women undergoing surgery to repair pelvic organ prolapse. Pelvic organ prolapse happens when organs like the bladder or womb drop down from their normal position. The study wants to see how effective this new mesh is at treating prolapse and if it makes a lasting difference. Researchers are also carefully monitoring any potential risks, side effects, and how it affects a woman's general well-being and daily life. The aim is to gather important information about the safety and performance of ProGYNious and help doctors decide if it's a good option for future patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

A.M.I. Agency for Medical Innovations GmbH

Enrolment target

100

Start

15 Apr 2026

Estimated completion

30 Sep 2028

Pelvic Organ Prolapse (POP)Synthetic Mesh Laparoscopic Surgery Gynecologic Laparoscopic Surgery Sacrocolpopexy Pelvic Floor Prolapse Pelvic Floor Implant

What is this study about?

This study is exploring a new type of surgical mesh, called ProGYNious, used in an operation to help women with a condition called pelvic organ prolapse. Pelvic organ prolapse happens when the muscles and tissues that support your organs in the pelvis, like your bladder, womb, or bowel, become weak. This can cause these organs to drop down and press into the vagina, leading to uncomfortable symptoms. The operation often uses a special mesh to help lift and support these organs back into place.

The ProGYNious mesh is made from two different types of strong but lightweight material. The main part of the mesh is very flexible and has wide holes, while the part that attaches to a bone in your lower back is stronger with smaller holes. This design is intended to provide good support while still allowing your body to heal and recover naturally. This study is taking place in several medical centres and will follow women over time to see how the mesh performs.

The main goal of this research is to see how well the ProGYNious mesh works in fixing pelvic organ prolapse and if it helps women feel better. They also want to understand any potential risks or side effects and how it impacts a woman's quality of life. By collecting information from women who have this surgery, doctors can learn more about how to best help patients with pelvic organ prolapse in the future.

Key takeaways

This study evaluates a new surgical mesh (ProGYNious) for pelvic organ prolapse.
It aims to confirm the mesh's effectiveness, safety, and impact on quality of life.
The mesh is designed to be flexible yet strong for organ support.
Participation involves having the surgery and attending follow-up checks.
Only women aged 18-80 with symptomatic prolapse are being considered.
There are specific health conditions that would prevent you from joining.

Who may be eligible?

This study is looking for women aged between 18 and 80 years old who are experiencing symptoms of pelvic organ prolapse and whose doctor thinks the ProGYNious mesh could be suitable for their surgery. You need to be able to attend follow-up appointments and understand what the study involves, including signing a consent form.

However, there are certain situations where you wouldn't be able to join. For example, if you have had cancer that could affect this type of surgery, if you're allergic to the mesh material, or if you have severe bone weakening (osteoporosis). Being pregnant, breastfeeding, or having unexplained bleeding would also mean you can't take part. If you've had previous mesh surgery for prolapse or urinary leaks, or if you have certain other health conditions like poorly controlled diabetes, serious long-term breathing problems, or a chronic pain condition, you wouldn't be eligible. The study also cannot include you if your general health means your life expectancy is very short or if you can't commit to the follow-up schedule.

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 18 and 80 years old?
Do you have uncomfortable symptoms from pelvic organ prolapse?
Is your doctor considering surgery with mesh to fix your prolapse?
Are you able to attend all planned follow-up appointments?
Have you never had mesh surgery before for prolapse or a leaky bladder?
Are you free from severe underlying health conditions like cancer, uncontrolled diabetes, or severe osteoporosis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have surgery to implant the ProGYNious mesh to repair your pelvic organ prolapse. After the surgery, you would need to attend follow-up appointments. These appointments will allow the healthcare team to check how well the mesh is working, monitor your recovery, and see if you are experiencing any side effects. They will likely ask you questions about your symptoms, your comfort, and your general well-being. The exact number and timing of these visits will be explained in detail by the study team, but they are crucial for gathering all the necessary information about the mesh's performance and safety. The total duration of your involvement will depend on the study's follow-up schedule, which aims to provide a comprehensive look at the mesh's long-term effects.

Potential risks and benefits

Taking part in this study means you would be among the first to receive this specific type of mesh during your prolapse surgery, which could potentially offer a new and effective way to treat your condition. However, as with any surgery, there are risks, including those related to the procedure itself, and potential side effects from the mesh, although the study aims to assess these thoroughly. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe
Verified postcode
Wiener Neustadt, Austria
Kardinal Schwarzenberg Klinikum
Verified postcode
Schwarzach im Pongau, Austria
Universitätsklinikum Erlangen, Frauenklinik
Verified postcode
Erlangen, Germany
Klinik Agatharied, Gynäkologie & Geburtshilfe
Verified postcode
Hausham, Germany
Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe
Verified postcode
Frankfurt am Main, Germany

Common questions

What is pelvic organ prolapse?

It's when organs like your bladder, womb, or bowel drop down from their normal place in your pelvis, often causing uncomfortable feelings or problems.

What is the ProGYNious mesh?

It's a special Y-shaped material used in surgery to help support and lift pelvic organs back into their correct position.

Why is this study being done?

The study wants to find out how well this new mesh works to fix prolapse, how safe it is, and if it helps women feel better after surgery.

Who can take part in this study?

Women aged 18-80 with symptomatic pelvic organ prolapse who are considered suitable for this type of surgery by their doctor.

What happens if I join the study?

You'd have the surgery with the ProGYNious mesh, then attend follow-up appointments so doctors can check your recovery and the mesh’s performance.

How to find out more

Florian Blab, MA

ca@ami.at +43 5522 90505-0 Official trial record

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