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Kidney and Urinary Tract clinical trial

Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial

Summary:
Around one in five men who undergo prostate surgery for cancer or benign disease subsequently need to use incontinence pads because of leakage of urine. This ruins their quality of life, greatly lowers their self esteem, stops them working and damages their personal relationships. At present the advised 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 important for the NHS to decide whether the male sling or AUS is better. The number of men needing this type of surgery is likely to increase in the future due to early prostate cancer diagnosis as a result of the wider use of the PSA blood test. The trial will take place in hospitals where surgeons are already experienced in carrying out both types of surgery. The success of surgery will be judged by the men’s report of urine leakage, using postal questionnaires at six and 24 months after AUS or male sling operation. Other outcomes we will measure will include men’s satisfaction with treatment, sexual function, quality of life, adverse effects and use of health services. The men will also be followed up in the longer term to make sure early success is maintained.

Inclusion criteria:
1. Adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery. 2. Men who are willing to be randomised between male sling and AUS (men who are not willing to be randomised can consent to follow-up).

Exclusion criteria:
1. Men who have had previous male sling or AUS surgery. 2. Men with unresolved bladder neck contracture or urethral stricture after prostate surgery. 3. Men who do not consent to be randomised (these men will be asked to consent to follow up). 4. Men with insufficient manual dexterity to operate AUS device. 5. Men who are unable to give informed consent or complete trial documentation.

Principal Investigator for this trial: Mr Richard J Parkinson

Research Ethics Committee Reference: 13/SW/0132

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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