i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
This study is investigating a medical device called i-Stitch, used during surgery for a common condition in women called pelvic organ prolapse. This happens when organs like the bladder or womb drop down, causing uncomfortable symptoms. The i-Stitch device helps to secure these organs back in place. While i-Stitch has been used with surgical mesh implants before, this particular study focuses on its use without mesh, specifically for a procedure called sacrospinous ligament fixation (SSLF). Researchers want to gather information to confirm that using i-Stitch in this way is both safe and effective for patients. It's a look back at existing patient data to understand the results better.
At a glance
What is this study about?
This study is about a medical device called i-Stitch, which is used during an operation to help women with pelvic organ prolapse. Pelvic organ prolapse happens when the muscles and tissues that support organs like the bladder, womb, or bowel in the pelvis become weak. This can cause these organs to drop down, leading to uncomfortable feelings of pressure or a bulge.
The i-Stitch device helps surgeons fix these organs back into their correct position. Think of it like a special tool that helps sew things up inside the body during surgery. It works by attaching sutures (surgical stitches) to body tissues. The focus of this research is specifically on a procedure called sacrospinous ligament fixation (SSLF), which is one way to treat this problem.
Previous studies have already shown that i-Stitch works well when used with a special surgical mesh. However, this study is different because it's looking specifically at how safe and effective i-Stitch is when it's used *without* any mesh. The researchers are reviewing information from women who have already had this type of surgery to see how well they did, aiming to confirm that using the i-Stitch device in this mesh-free way is a good option for patients.
Key takeaways
- The study looks at an existing surgical tool called i-Stitch.
- It aims to confirm the safety and effectiveness for pelvic organ prolapse repair.
- Specifically focuses on using i-Stitch *without* surgical mesh.
- This is a review of past patient records, not a new treatment trial.
- Information gathered will help improve future treatment options for women.
- Your private information remains confidential.
Who may be eligible?
To be considered for this study, you would need to be a woman aged 18 or older who has had surgery for pelvic organ prolapse (POP). Crucially, the i-Stitch device must have been used during your specific sacrospinous ligament fixation (SSLF) procedure.
It's okay if other procedures were done at the same time as your POP surgery. Before your surgery, you would also have needed to give your written permission to your doctors for them to use your information for studies like this one.
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 aged 18 or older?
- Have you had surgery for pelvic organ prolapse?
- Was the i-Stitch device used during your specific prolapse surgery?
- Did you give written permission for your medical information to be used for research before your surgery?
- Have you *not* had any active infections, severe allergies, or certain blood/autoimmune conditions?
What does participation involve?
Please note, this is a *retrospective* study. This means that researchers are looking back at information from people who have already had surgery. You wouldn't be actively taking part in new treatments or tests. Instead, if you meet the requirements, your existing medical records from your surgery would be reviewed by the study team. You wouldn't need to attend extra appointments, take any new medications, or have any additional follow-up specifically for this study. The study simply uses information that's already there.
Potential risks and benefits
Locations (1)
- Isar Kliniken GmbHVerified postcodeMunich, Germany
Common questions
What is pelvic organ prolapse?
It's when organs like your bladder or womb drop down from their normal position due to weakened support.
What is the i-Stitch device?
It's a special surgical tool used by doctors to help fix organs back in place during a prolapse operation.
Is this study giving me new treatment?
No, this study is looking at information from people who have already had surgery for prolapse in the past.
Why is it important to study this?
Understanding how well i-Stitch works without mesh helps doctors make better decisions for future patients and improve care.
Will my personal details be shared?
No, your medical information will be kept private and anonymised, meaning your name and personal details won't be used.
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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