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RecruitingNAINTERVENTIONAL

Synthetic Versus Autologous Sling For Stress Incontinence

This study is looking at two types of surgery for women over 60 who experience stress urinary incontinence, which means leaking urine when they cough, sneeze, or exercise. One surgery uses a synthetic tape, and the other uses a piece of tissue taken from your own body to create a sling. Doctors want to see which method works best, focusing on new pain six months after surgery and how well the leaks are stopped five years later. They will also check on things like mental health, sexual health, and if patients need pain medication after the operation. By comparing both options, the study aims to find the safest and most effective treatment for stress incontinence in older women.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of British Columbia
Enrolment target
232
Start
12 Jan 2026
Estimated completion
01 Dec 2032
Urinary Incontinence

What is this study about?

This important study is designed for women aged 60 and over who are experiencing stress urinary incontinence. This condition causes involuntary leakage of urine, often when you laugh, cough, sneeze, or exercise. The study is comparing two different surgical approaches commonly used to treat this problem. One is called a 'tension-free vaginal tape' (TVT), which uses a synthetic (man-made) mesh tape to support the urethra. The other is an 'autologous fascia sling' (AFS), where a sling is created using a strip of strong tissue taken from your own body, often from your tummy or thigh.

The main goal of the study is to see which of these two surgeries causes less new pain six months after the operation. It also wants to find out which surgery is more effective at stopping urine leaks five years down the line. Researchers will be carefully observing how patients recover, their overall well-being, and how the surgery impacts their daily lives.

This research is really important because it will help doctors understand which surgical option might be best for older women with stress incontinence. By looking at long-term results, including factors like mental health, sexual health, and the need for pain medication, the study aims to improve treatments and quality of life for many women.

Key takeaways

  • Compares two surgical options for stress urinary incontinence.
  • For women aged 60 and over who have tried other treatments.
  • Looks at pain 6 months after surgery and cure rates after 5 years.
  • Also studies mental health, sexual health, and pain medication use.
  • Requires follow-up visits over a five-year period.

Who may be eligible?

This study is looking for women who are 60 years or older and have stress urinary incontinence that's severe enough to consider surgery. You should have already tried other non-surgical treatments like pelvic floor exercises (Kegels) or physiotherapy, and they haven't worked well enough. You also need to have finished having children and be able to attend follow-up appointments for up to five years after the surgery.

There are some reasons why you wouldn't be able to join the study. For example, if you are very frail, have certain bladder conditions, or have recently had other pelvic surgery. If you've had surgery for urinary incontinence before, or if you've had radiation treatment in your pelvic area, you wouldn't be eligible. Also, if you've had persistent pelvic pain recently or if you're taking strong medications that affect your immune system, you might not be able to take part.

Finally, if you're a smoker, you would need to be able to stop smoking for at least three months before surgery and be able to stay smoke-free afterwards to be considered for the study. The doctors also need to be sure you'll be able to come to all the follow-up visits.

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.

  1. Are you a woman aged 60 or older?
  2. Do you experience urine leaks when you cough, sneeze, or exercise?
  3. Have you already tried pelvic floor exercises or physiotherapy for your leaks?
  4. Have you finished having children?
  5. Are you able to attend follow-up appointments for up to five years?
  6. Have you had persistent pelvic pain for more than 3 months in the last 5 years? (If yes, you might not be eligible)
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a thorough check-up to make sure you're suitable. Once enrolled, you would be randomly assigned to receive one of the two types of surgery: either a synthetic tape sling or a sling made from your own body tissue. You wouldn't be able to choose which surgery you receive. After your surgery, you would have several follow-up appointments at the clinic over five years. These visits would involve check-ups to see how you're recovering, how well the surgery has stopped your urine leaks, and to discuss any pain, your mental health, and sexual health. You might also be asked about any pain medication you're taking. The total duration of your participation would be five years, including the surgery and all follow-up appointments. There are no study medications involved, but your regular medications would be monitored.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of joining this study is that you would receive one of the established surgical treatments for stress urinary incontinence, which could significantly improve your quality of life by reducing urine leakage. You would also receive close medical attention and monitoring for five years. However, like any surgery, both procedures carry risks, such as infection, bleeding, pain, or injury to surrounding organs. It's also possible that the surgery might not fully resolve your incontinence, or you could experience new symptoms like pain. 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· Recruiting

Common questions

What is stress urinary incontinence?

It's when you accidentally leak urine because of pressure on your bladder, for example, when you cough, sneeze, laugh, or exercise.

What's the difference between the two surgeries?

One uses a man-made tape to support your bladder, and the other uses a piece of your own body tissue to create a natural sling.

How long will I be involved in the study?

You'll be involved for five years in total, including your surgery and regular check-ups.

Do I get to choose which surgery I have?

No, you would be randomly assigned to one of the two surgery types, like flipping a coin.

What if I change my mind about participating?

You are free to leave the study at any time, and it won't affect any future medical care you receive.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "Synthetic Versus Autologous Sling For Stress Incontinence…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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