MASTER - Male synthetic sling versus Artificial urinary Sphincter Trial: Evaluation by Randomised controlled trial

Around one in five men who undergo prostate surgery for cancer or benign disease need to use incontinence pads because of leakage of urine when they walk around, cough, or do any physical exertion.  This ruins their quality of life, greatly lowers their self-esteem, stops them working, and damages their personal relationships.  

Click here to read a recent article published in Trends in Urology and Mens Health detailing the aims of the MASTER trial (published Mar/Apr 2015).

At present the traditional surgical treatment is insertion of a plastic artificial urinary sphincter (AUS) device, which involves a major operation to place an inflatable cuff around the urine pipe close to the bladder, and inflating it to prevent leakage. The man then has to deflate the cuff by repeatedly squeezing a pump placed in his scrotum, to allow him to pass urine when needed.  Recently, a new male sling has been developed which, when inserted under the urine pipe, supports the outlet of the bladder but doesn’t need a pump.  It is easier to insert, but some men may still need a subsequent operation to place an AUS if they feel their incontinence has not improved enough.  It is also uncertain whether there are other advantages or disadvantages compared to the AUS, and whether men will be as satisfied with the results.

There is no scientific evidence to show which of these two surgergies is best for any severity of incontinence.  MASTER will be the first trial to compare these two incontinence treatments and provide this evidence for men with incontinence in the future.

It is important for the NHS to decide whether the male sling or AUS is better because the number of men needing this type of surgery is likely to increase.  This is because more men are requiring surgery for early prostate cancer with wider use of the PSA blood test. If our trial shows that the male sling is as good as the AUS and is preferred by men having this surgery, it will help men, their doctors and the NHS planners decide which treatments should be available.

We will ask men who are considering having surgery for urine leakage to consent to treatment with either the male sling or AUS. The type of surgery will be decided at random by computer.  Computer randomisation is the most ethical and appropriate design because it gives a fair comparison between the treatments and allows us to be sure that any differences between the results for the two operations are due to the treatment they received in the trial, and not due to other differences which we cannot measure.

For more information click here to access the patient information leaflet, or find more information in the public documents folder on the left-hand menu.

To contact the MASTER trial team email master@abdn.ac.uk or phone on 01224 438096.

This project is funded by the National Institute for Research Health Technology Assessment Programme (project number 11/106/01).  The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR or Department of Health.