Active not recruitingOBSERVATIONAL

Retrospective Data Analysis PelviGYNious/EndoGYNious

This research is reviewing past patient information to learn more about the safety and effectiveness of two medical devices called PelviGYNious and EndoGYNious. These devices are used during surgery to help support organs that have dropped or bulged into the vagina, a condition known as pelvic organ prolapse. The study aims to gather more evidence on how well these devices work and how safe they are for women who have undergone this type of surgery. It's an important step in understanding the long-term results for patients and ensuring the devices continue to be a good option for treatment.

At a glance

Status

Active not recruiting

Sponsor

A.M.I. Agency for Medical Innovations GmbH

Enrolment target

Start

01 Apr 2024

Estimated completion

01 Aug 2025

Prolapse Sacrocolpopexy Pelvic Organ Prolapse (POP)

What is this study about?

This study is reviewing information from patients' past medical notes to better understand two special medical devices called PelviGYNious and EndoGYNious. These devices are used in surgery to help support the pelvic organs that may have "dropped" or moved out of place, a condition often called pelvic organ prolapse. This can happen when the muscles and tissues that hold these organs in place become weak.

The main goal of this study is to gather more details about how safe and how well these devices have worked for women who have already had them placed during surgery. By looking back at what happened with these patients, researchers hope to get a clearer picture of the long-term results and confirm that these devices are a good and safe choice for treating pelvic organ prolapse.

This kind of research, called a 'retrospective' study, is important because it uses existing information to learn more about medical treatments in real-world situations. It helps doctors and patients make informed decisions about care for pelvic organ prolapse.

Key takeaways

Study reviews past patient records for PelviGYNious and EndoGYNious devices.
Aims to understand safety and performance of devices for pelvic organ prolapse.
No active patient participation; data comes from existing medical notes.
Focuses on women aged 18 and over who had specific prolapse surgery.
Contributes to better information for future pelvic organ prolapse treatments.

Who may be eligible?

This study is looking at information from women who have already had surgery for pelvic organ prolapse (when pelvic organs drop or bulge).

To be included, women needed to have had one of the PelviGYNious or EndoGYNious devices implanted during their surgery. They also had to be at least 18 years old at the time of their surgery and have given written permission for their medical information to be used for research.

Some women would not be included if they had certain health conditions at the time of their surgery, such as being pregnant, having an allergy to plastic materials, certain infections, or other serious health issues that would make using the device unsafe or difficult. Patients who previously asked the hospital not to contact them for research purposes would also be excluded.

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.

I had surgery for pelvic organ prolapse.
One of the devices, PelviGYNious or EndoGYNious, was used in my surgery.
I was at least 18 years old when I had the surgery.
I gave written consent for my surgery.
I do not have a record of asking the hospital not to contact me for research before.

Answer every question to see your result.

What does participation involve?

Since this is a 'retrospective' study, it means researchers are looking back at information that has already been collected in patients' medical records. You would not need to attend any appointments, take any new medications, or undergo any extra tests. Your existing medical notes would simply be reviewed by the research team. There is no direct involvement for you as a patient once the study begins, and therefore no follow-up visits or specific duration for your participation.

Potential risks and benefits

Because this study only reviews existing medical records, there are no direct physical risks to patients. Your privacy is protected, as personal information is kept confidential. There are no direct benefits to individual patients by participating, but the information gathered can help improve understanding of the safety and effectiveness of these treatments for future patients with pelvic organ prolapse. You would not need to withdraw from anything, as the study is reviewing past data, not current treatment.

Locations (1)

Universitätsklinikum Erlangen, Frauenklinik
Verified postcode
Erlangen, Germany

Common questions

What is pelvic organ prolapse?

Pelvic organ prolapse is when organs like the bladder, womb, or rectum can drop down and bulge into the vagina because the supporting muscles and tissues are weak.

What are PelviGYNious and EndoGYNious?

These are medical devices, like special types of mesh, used during surgery to help support the pelvic organs and fix pelvic organ prolapse.

Will I need to do anything if I'm part of this study?

No, if your records are included, you won't need to do anything. This study looks back at old medical notes, not involving new patient visits or tests.

Is my personal information kept private?

Yes, all personal and medical information used in research studies is handled with strict confidentiality to protect your privacy.

What's the point of this study?

The study aims to gather more evidence on how safe and effective these devices have been for patients over time, which helps doctors make better treatment choices in the future.