Active not recruitingNAINTERVENTIONAL

Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial

This study is looking into the best surgical method for women experiencing pelvic organ prolapse, where the vagina or other pelvic organs drop and cause discomfort. It aims to compare a newer technique that uses a synthetic mesh with the current standard method that relies on stitches. Both surgeries involve placing support at the top of the vagina. The researchers want to see which approach works better over two years in terms of how successful it is, how long the repair lasts, and if it saves money in the long run. Patients and the medical team assessing the results won't know which technique was used, making the study very fair.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

358

Start

01 Nov 2016

Estimated completion

01 Nov 2026

Pelvic Organ Prolapse

What is this study about?

Pelvic organ prolapse (POP) happens when the muscles and tissues that support your pelvic organs weaken, causing organs like your bladder, womb, or rectum to bulge into the vagina. This is quite common, especially after childbirth and as women get older. For some women, it causes bothersome symptoms, and surgery might be an option to lift and support these organs back into place.

This study is trying to find the very best way to do this type of surgery when it’s performed through the vagina. Vaginal surgery is often preferred because it usually means less pain, a shorter stay in hospital, and a quicker recovery compared to other types of surgery. The study will compare two surgical methods: one that uses special stitches to hold things up, and a newer technique that uses a synthetic mesh. The main goal is to see which method provides the most successful, lasting repair.

The researchers are particularly interested in whether using mesh helps the repair last longer and if it's a good value for money over time. They will follow women for two years to see how well each method works, how comfortable women feel, and if they need any further treatment for prolapse. Both you and the healthcare professionals checking your progress won't know which type of surgery you had, which helps make the results as accurate as possible.

Key takeaways

Compares two surgical methods for pelvic organ prolapse: mesh vs. stitches.
Aims to find the most successful and lasting surgical repair.
Patients won't know which technique they received (called 'blinded').
Participation involves surgery and follow-up visits for two years.
Helps advance understanding of the best prolapse treatments.

Who may be eligible?

To join this study, you need to be a woman over 19 years old who has been diagnosed with bothersome pelvic organ prolapse at the top of the vagina. You should be able to read and understand English, and be able to attend follow-up appointments for up to two years after your surgery.

There are certain reasons why you might not be able to join. For example, if you want to keep your womb, or if you've had radiation treatment in your pelvic area before. You also can't take part if you've previously had mesh surgery for prolapse or if you currently have pain from muscle spasms in your pelvic floor. If you're a smoker, pregnant, or breastfeeding, you also wouldn't be able to join.

Also, if you have certain health conditions that might make you more sensitive to pain, like fibromyalgia or painful bladder syndrome, you wouldn't be suitable. The study is very specific about where the mesh might be used, so if you need mesh in other parts of your vagina at the same time, this study might not be right 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 a woman over 19 years old?
Do you have bothersome pelvic organ prolapse at the top of your vagina?
Can you read and understand English well?
Can you attend clinic visits for two years after surgery?
Have you NOT had previous mesh surgery for prolapse?
Are you NOT pregnant, breastfeeding, or a current smoker?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have surgery to repair your pelvic organ prolapse. The study will decide by chance whether you have the standard surgery with stitches or the new surgery with mesh. You won't know which one you've had, and neither will the doctors checking your progress.

After your surgery, you'll need to attend regular check-up appointments at the clinic for up to two years. These visits will help the doctors see how well the surgery has worked and how you are feeling. Throughout this time, your feedback on your comfort and well-being will be very important. The total duration of your participation, including follow-up, will be two years.

Potential risks and benefits

Taking part in this study might benefit you by providing a potentially more effective or longer-lasting surgical repair for your pelvic organ prolapse. It also contributes to finding the best treatment options for other women in the future. As with any surgery, there are potential risks, including side effects from anaesthesia, infection, bleeding, and potential complications specific to the surgery itself, which your doctor will discuss thoroughly with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St. Paul's Hospital
Verified postcode
Vancouver, Canada

Common questions

What is pelvic organ prolapse?

It's when organs like your bladder or womb drop into your vagina due to weakened support, causing discomfort.

What is the main goal of this study?

To find out if using mesh or stitches is better for fixing pelvic organ prolapse in surgery, looking at success and how long it lasts.

Will I know which surgery I had?

No, both you and your doctors assessing results won't know if you received the mesh or stitch technique to keep the study fair.

How long will I be in the study?

You will be followed for up to two years after your surgery to check your progress.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any point without it affecting your usual medical care.