A trial of devices designed to prevent or contain persistent urinary leakage following prostate cancer

University of SouthamptonDr Mandy Fader£106,5172009 - 2011

Why we funded it

The results of this project should help us find out which incontinence management product, or combination of products, performs better. Dr Fader hopes this will provide more effective treatment choices for men managing urinary incontinence after prostate cancer surgery.

 

Scientific title

A trial of devices for intractable urinary incontinence following prostate cancer surgery.

 

Research project summary

The project will carry out a clinical trial of devices for managing urinary incontinence (leakage from the bladder) in men who have persistent leakage after prostate surgery for cancer.

Around 10-15% of men experience persistent urinary incontinence after surgical removal of the prostate. This incontinence can be very distressing and is known to have a profoundly negative effect on men's lives, often affecting social activities, personal relationships and mental well-being. Most men are provided with absorbent pads to contain their incontinence (they are easy for nurses to prescribe and do not require any skilled fitting) but these have disadvantages and men often find larger pads to be bulky, feminine or babyish.

The study invites men who have had prostate cancer surgery and who are currently using absorbent pads to test three male devices (described in detail below) in a random order and after expert fitting. Each participant will test each device for up to two weeks and then complete a questionnaire on product performance which has been tested and used before in other trials. Participants will also be asked to complete the questionnaires for their usual absorbent pads. The most important outcome will be the 'overall opinion' of the device/pad, and (after testing all the devices) preference for each (for different situations/circumstances) when compared to the other devices and the usual absorbent pad. In addition we will measure whether use of the devices improves quality of life.

The trial will take two years to complete. It will provide new information about the effectiveness of male devices and absorbent pads for the management of persistent incontinence following prostate cancer surgery, and the effects on quality of life. This evidence will enable nursing and continence services to provide better services and optimum continence products to such men and will help the Prostate Cancer Charity and other charities such as the Bladder and Bowel Foundation to provide appropriate product advice, support and information to men with prostate cancer and incontinence.

Read more about the 3 devices to be tested here.

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3 devices under trial for urinary control

For men with prostate cancer the development of persistent urinary incontinence can be a dreadful additional blow. Successful management with continence products is crucial to maintaining quality of life and enabling men to live their lives confidently. If male devices are found to be better than (or as good as) absorbent pads then men will be given a much wider range of products to choose from than currently is the case and this should lead to better continence management and less blighted lives for men with prostate cancer and incontinence.

There are three other main types of products which are specifically designed for men with urinary incontinence; these male devices are (i) sheath drainage systems (similar to a condom attached to a drainage bag), (ii) male collection devices (a cone or pouch device held over the penis by a belt or straps, with an integral collection bag, (iii) penile compression device (which compresses the penis to prevent - rather than contain - urine leakage). Although these devices are readily available on prescription (except for the penile compression device which is self-purchased) they are used much less commonly than pads, probably because little research has been carried out on them and it is known that nurses lack knowledge and skills in fitting them. Some experts think that these male devices may be better than pads, particularly for some circumstances or situations (e.g. day/night, going out/staying in) but there is little published about them and nurses and other prescribers cannot be encouraged to offer them as a choice or learn how to fit them properly if we do not have evidence that they work better than (or as well as) pads.