Taking part in the study will involve attending 2 extra hospital appointments:

• An initial screening visit to consent to the study and to check that you are eligible, (this visit may be combined with one of your usual visits)
• A follow-up appointment a year after your procedure

You will also need to fill in some questionnaires prior to your procedure and then again at 6 weeks, 6 months, 1 year, 2 years and 3 years after your procedure.  The answers to these questionnaires will help us to find out how effective your procedure was.  As a thank you for your time, you will receive a £25 gift voucher on completion of questionnaires at 2 years and 3 years post-procedure.

Taking part in the study means that you will undergo a procedure to treat your benign bladder outlet obstruction.  You will have chosen which procedures you are willing to undergo and will then be assigned one of these procedures at random.  This happens in order to keep the study fair and to ensure that the pros and cons of each procedure can be compared equally.  You will find out which procedure you were allocated to either at your screening visit or a few days afterwards.

Please be aware that there is often a waiting list for procedures within the NHS.  Your doctor will be able to let you know if this is likely to be the case.  The waiting times may vary for the different procedures, but your participation in the the study will not affect your position on the waiting list.  Sometimes procedures take place at another local hospital, rather than the hospital you usually attend for visits.  The amount of time you spend in hospital for the procedure and any follow-up appointments required will vary depending on which procedure your receive.  You will receive normal NHS treatment whether you take part in the study or not, although some of the treatment options may not usually be an option at your local hospital outside the study.

The extra hospital appointment one year after your procedure will take place with a member of the research team. At this appointment you will have a test to find out how fast your urine flows and how much urine is left in your bladder after you have urinated. You may have had a similar urine flow test when you were diagnosed. For this test, you will urinate into a special funnel that is connected to a measuring device. This appointment will take approx. 30-45 minutes.

VISIT TIMELINE

Visit 1 : Screening (at hospital)

You will give your consent to take part in PREMISE.  All of your questions will be answered and the team will ask you about your medication and health.  You may have some assessments including: a scan of your prostate, a digital rectal exam and a urine flow test.  You will complete a set of questionnaires.  You will make your treatment choices.

Visit 2 : Baseline (phone call)

Depending on how long you have to wait for your procedure, you may be asked to repeat completion of your questionnaires.

Visit 3 : Procedure (at hospital)

You will receive one of your chosen procedures.

Visit 4 : 6 weeks after Procedure (phone call)

One of the research team will call you and ask you some questions about your symptoms and how you have been since your procedure, and whether you have needed a catheter.  You will complete a set of questionnaires.

Visit 5 : 6 months after Procedure (phone call)

One of the research team will call you and ask you some questions about your symptoms and how you have been since your procedure, and whether you have needed a catheter.  You will complete a set of questionnaires.

Visit 6 : 12 months after Procedure (at hospital)

You will have a urine flow test.  One of the research team will ask you some questions about how you have been since your procedure and whether you have needed a catheter.  You will complete a set of questionnaires.

Visit 7 : 2 years after Procedure (phone call)

You will complete a set of questionnaires and receive an update on the trial progress.  You will receive a £25 gift voucher for completing the questionnaires.

Visit 8 : 3 years after Procedure (phone call)

You will complete a set of questionnaires and receive an update on the trial progress.  You will receive a £25 gift voucher for completing the questionnaires.