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A trial comparing 2 devices to help men with urine leakage after prostate cancer surgery (MASTER)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing 2 devices to help men with urine leakage (urinary incontinence) after having surgery for prostate cancer.
More about this trial
Doctors can treat prostate cancer by removing the prostate gland or removing part of the prostate gland. As with all types of surgery there may be long term side effects. One long term side effect after prostate surgery is a problem controlling the flow of urine (urinary incontinence).
Doctors can help men in this situation by doing more surgery to fit a device that helps men control their flow of urine. This device is called an artificial urinary sphincter. It involves putting an inflatable ring around the tube that carries the urine from the bladder to the outside of the body (urethra). The ring is attached to a small pump in your scrotum that you use to deflate the ring when you want to pass urine.
There is another device called the male sling. The male sling is a flexible net that is put around the urethra. It acts like a hammock providing support for the urethra. The male sling doesn’t need a pump to work.
The surgery needed to put the male sling in place is a little simpler than to put the artificial urinary sphincter in. But at the moment there isn’t enough evidence to say if the male sling is as good as the artificial urinary sphincter. The researchers want to compare the 2 devices to find out if the male sling is as good as the artificial urinary sphincter. The National Institute for Health and Care Excellence (NICE) has said that because of the uncertainty about the male sling, it should only be used in a trial like MASTER.
The researchers aim to find out
- What the costs are of putting both devices in
- What are the side effects or complications of each type of surgery to put the devices in
- How each device affects men’s quality of life and their general health
- How satisfied men are with their operation and the device they have
Who can enter
You may be able to join this trial if all the following apply. You
- Are an adult male
- Have had surgery for prostate cancer
- Have problems with urine leakage (urinary incontinence) following your surgery
- Have decided to talk to your doctor about having further surgery to fix your urine leakage
You cannot join this trial if any of these apply. You
- Have already had surgery to fix your urine leakage
- Have an ongoing problem with a narrowing of your
urethraor your bladderfollowing your prostate cancer surgery
- Are not able to work the artificial urinary sphincter device
This is a phase 4 trial. Everyone taking part in this trial will have surgery to fix their urinary leakage (incontinence).
You see a doctor who specialises in treating urinary incontinence (urologist).
There are 2 different devices used in the MASTER trial to help your leakage. If your urologist thinks that either device may work just as well for you, with your agreement you will be put into 1 of 2 groups at random. Neither you nor your urologist will be able to decide which group you are in. The researchers need 360 men to join the trial.
- Men in group 1 will have the artificial urinary sphincter
- Men in group 2 will have the male sling
After your operation the trial team will tell you which device you have.
Everyone in the trial will fill out a questionnaire before their surgery, and then at 6 months, 1 year and 2 years after surgery. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
A year after your surgery the researchers will ask you to do a urinary pad test. This measures the amount of urine that leaks out over a 24 hour period. You wear absorbent urinary pads for 24 hours. You take the pads to the hospital to be weighed.
They will also ask you to keep a diary for 3 days each time you fill in the questionnaire. You need to record
- How often you go to the toilet to pass urine
- How often you have some urine leakage
- How often you get up at night to pass urine
- How many urinary pads you use
- How many times you wet your clothes
The team may also ask you to take part in an interview. They want to know about your expectations and point of view on urine leakage after having prostate cancer surgery. This can be done either over the telephone or in person. If they do contact you don’t have to agree to do it if you don’t want to. You can still take part in the main trial.
You take the diary, questionnaires and the urinary pads to one of your routine hospital appointments, so there will be no extra hospital visits.
To put the male sling in is usually a 1 day stay in hospital. For the artificial urinary sphincter it is usually a 1 or 2 day stay in hospital.
Complications and side effects of this type of surgery are rare but can include infection and damage to the tube that carries urine from the bladder to the outside of the body (urethra).
Your doctor will talk to you about the possible complications and side effects of having this type of surgery.
How to join a clinical trial
Professor Paul Abrams
Trials and Studies Coordinating Centre (NETSCC)
NIHR Health Technology Assessment (HTA) programme
North Bristol NHS Trust