Trial Procedures

There are 4 different procedures being compared in the PREMISE Trial:

TURP

A transurethral resection of the prostate (TURP) is a keyhole surgical procedure that involves cutting away a section of the prostate. General or spinal anaesthesia is used during the procedure. You'll usually need to stay in hospital for 1-to-3 days after your operation, although at some hospitals you can go home on the same day. A catheter (a tube coming out of the penis to drain the bladder) is used after the operation and this will usually be taken out between 1 day and 1 week afterwards.

In most cases, TURP is a safe procedure and the risk of serious complications is small.

However, many men who have a TURP lose the ability to ejaculate semen during sex or masturbation, although they still have physical pleasure from ejaculation (orgasm). This is known as retrograde ejaculation. Some men also lose the ability to control their bladder (urinary incontinence), although this usually passes in a few weeks. In rare cases (less than 2 in 100), it may be persistent and need further treatment. There's also a risk of problems such as erectile dysfunction (10 in 100), bleeding (more than 10 in 100), difficulties passing urine (less than 5 in 100) and urinary tract infections (UTIs) (less than 20 in 100).

Rezum Water Vapour Therapy

Rezum Water Vapour Therapy is a surgical treatment that involves a special machine injecting steam into the prostate which causes the prostate to shrink down in size a few weeks later. The procedure takes less than 10 minutes to complete and patients are normally able to go home the same day. It is usually performed under sedation or general anaesthesia. A catheter is always left in after the procedure for 5-10 days.

Bleeding and UTIs after the procedure are common (more than 10 in 100), as well as discomfort passing urine. It does take up to 3 months to notice an improvement in symptoms. This is not the case with some of the other options where the improvement is often noticed within the first few days after catheter removal. This procedure is unlikely to change sexual or ejaculatory function. Urinary incontinence is rare (less than 1 in 100) following this procedure.

Prostatic Urethral Lift (Urolift)

This procedure involves passing a telescope through your urethra and putting two or more implants into your prostate to compress and open up the obstructing prostate. It is designed to improve your urinary flow without the need for burning or removing any prostate tissue. The procedure takes 10-15 minutes to complete and patients are normally able to go home the same day. It is generally performed under local anaesthesia or spinal / general anaesthesia. You do not usually need to have a catheter put in after this procedure.

You are likely to have some pain on passing urine, pelvic discomfort and frequent urination for a few weeks after the procedure. Sexual side-effects such as retrograde ejaculation or erectile dysfunction are rare, (less than 1 in 100). The implants are permanent and can affect the diagnostic quality of MRI scanning of the prostate if needed in the future, although you can still have an MRI scan.

Temporary Implantable Nitinol Device (iTIND)

This procedure involves placing a temporary implant (iTIND) into your prostate. Once in place, it will begin to expand and gently exert pressure on 3 points within the urethra, creating new channels for urine to exit the bladder. Once the iTIND is in place, you should be able to urinate freely, without the need for a catheter and it is done as a day case procedure under sedation, spinal anaesthetic or general anaesthetic. It is removed after 5-7 days under local anaesthesia.

Some men find the iTIND implant uncomfortable, but these symptoms usually disappear within a day or two of the device being removed. Sexual side-effects such as retrograde ejaculation or erectile dysfunction are rare seen after this procedure, (less than 1 in 100).