UPSTREAM is a study for men who have urinary symptoms, such as difficulty passing urine. Your doctor has referred you because the symptoms are causing you bother and you are seeking further treatment. As men get older they often experience lower urinary tract symptoms (LUTS) which can affect their quality of life, such as needing to pass urine more frequently or dribbling. 

These symptoms can be the result of the prostate growing larger and getting in the way of urine flow, which is called ‘benign prostatic obstruction’ (BPO).  BPO is the most common reason for urination problems in men. However, not all men with LUTS have enlarged prostates and for some men symptoms are caused not by the prostate but by a bladder problem, such as weakness of the bladder muscle. 

There are various possible treatments for men with LUTS, for example prostate surgery. However, choosing the treatment depends on working out what is causing the symptoms. For example, prostate surgery may not be sensible if the prostate is normal, and the cause of the symptoms is actually the bladder.

When assessing men with LUTS, there are two main approaches used in NHS hospitals. The most commonly used is to do a physical examination and a test called ‘uroflowmetry’ or ‘flow rate testing’. 

This test measures the flow of the urine stream and how well the bladder has emptied, showing how severe a man’s symptoms are.  However uroflowmetry cannot work out the cause of the symptoms, whether it is BPO or bladder weakness.  So, some hospitals also do a test called ‘urodynamics’, which measures how much pressure the bladder generates when the man is passing urine, and this is used to prove whether BPO is present. 

When the man has completed his assessment tests, he will discuss with his urologist to discuss what the most appropriate treatment is for his symptoms, which may include whether surgery for BPO is appropriate.  For those men not having urodynamic tests, proceeding to surgery is based on a presumption that BPO is the cause of the problem, while for the men having urodynamic tests, BPO would be proven.

This study will invite men who have bothersome LUTS to take part.  These men will be split into two groups (by chance).  Both groups will receive usual care, which includes completing a standard set of assessments used in the NHS, such as questionnaires about your symptoms, a bladder diary, a physical examination and a urinary flow test (uroflowmetry). 

One group will also go on to have urodynamic testing in addition to usual care.  We will then ask these two groups of men about their experiences and follow-up their longer-term health and symptoms. 

At present we don’t know whether using urodynamics as an additional assessment for men with bothersome LUTS is better than assessment without urodynamics. What we want to find out with this study is firstly, to check what the results of treatment are for men being assessed with or without urodynamics. Secondly, we would like to compare the number of men who had surgery for their symptoms, in the two groups.

We are also very interested in finding out how the men felt about having the assessment procedures. This study aims to provide evidence to help doctors and the NHS decide whether urodynamics should be more widely used for the assessment of men with LUTS who are seeking further treatment, such as surgery.

You are being invited to take part in the UPSTREAM trial because you are experiencing LUTS and are seeking further treatment, which may include the possibility of having surgery for your symptoms.

No, it is up to you to decide whether or not to take part. If you do decide to take part you will be given a patient information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw or not to take part will not affect the standard of care you receive now or in the future.

We expect around 800 men to take part in the study.  This group will be split into two groups by chance (randomisation).  Both groups will receive usual care, which includes completing a standard set of assessments used in the NHS, such as questionnaires about your symptoms, a bladder diary, a physical examination and having their symptoms assessed by uroflowmetry.

One of the groups will also go on to have their symptoms assessed by urodynamics as well (i.e. usual care plus urodynamic assessment).  All men will then meet up with their urologist, who will refer to the results of the tests to recommend what treatments you might consider. 

You will be able to choose which treatment you actually receive; in other words, your treatment will not be chosen by chance (at random), and you do not have to accept the urologist’s recommendation.

There is a flowchart (PDF, 295kB) which charts possible journeys through the study.  The following is a summary of what you will be asked to do if you decide you would like to take part and agree to be randomised to one of the diagnostic assessment groups.

Clinical visits include:

• Pre-assessment (all men): the doctor or nurse will check your symptoms using uroflowmetry
• Urodynamics visit (only men in Urodynamics group)
• Treatment decision (all men): to discuss your results and to decide on the most appropriate treatment, such as whether to have surgery
• 4 months after surgery (only men who chose to have surgery): there will be a clinic visit for another uroflowmetry test
• 18 months visit (all men): the doctor or nurse will check your symptoms using uroflowmetry

So, if you are in the Uroflowmetry (i.e. usual care only) group you may be invited to up to 3 visits to clinic (or 4 if you chose to have surgery), and if you are in the Urodynamics group you may be invited to up to 4 visits to clinic (or 5 if you chose to have surgery).

The number of visits may be less, depending on the set-up at your local hospital; your research nurse or urologist, will be able to advise you. 

You can reclaim travel and parking expenses if you have to come to the hospital specifically for the purposes of this study (that is for non-routine visits to the hospital).

You will be given questionnaires to complete at these points in the study:

• At Pre-assessment clinic (all men): questionnaires about urinary symptoms, sexual function and costs you might have incurred because of your symptoms
• After the urodynamics assessment (only men who have the urodynamics assessment): a short satisfaction questionnaire about the test
• At 6 and 12 months into the study by post (all men): about symptoms and sexual function and about costs you might have incurred because of your symptoms
• At 18 months clinic visit (all men): about symptoms and sexual function and about costs you might have incurred because of your symptoms

So, if you are in the Uroflowmetry (i.e. usual care) group you will be asked to complete 4 sets of questionnaires (1 each at 0, 6, 12 and 18-months), and if you are in the Urodynamics group you will be asked to complete an additional, short questionnaire following the test.  Each set of questionnaires will take 10-25 minutes of your time to complete.

We also plan to interview up to 45 patients about their experiences with LUTS and the treatment they have received. If you agree to being contacted, a researcher will arrange a mutually convenient time and location to discuss the interview and ask for your consent. The interview will take up to one hour.

At any stage you can decide to withdraw from the study. Your doctor will look after you normally, the same as if the study were not happening at all. Withdrawing from the study will not affect your medical treatment in any way. Throughout the study you are free to consult your own GP at any time. If you wish to withdraw from the study, please contact an UPSTREAM research nurse using the contact details on the participant information sheet.

You have been invited to take part in this study because you are experiencing bothersome LUTS and are seeking further treatment, which may include surgery. If you decide to take part in this study you will be randomised by chance into a group that will be assessed by uroflowmetry alone or a group assessed by both uroflowmetry and urodynamics before deciding deciding on the most appropriate treatment, including whether or not to have surgery.  

Both groups will be assessed with standard clinical pathways used currently in NHS Hospitals. Those randomised into the Urodynamics group, may have to wait 4-6 weeks for the test to be arranged, and an additional visit to the hospital will be needed for the tests to be carried out; travel expenses and parking can be reclaimed for this visit.

In addition urodynamic testing involves the insertion of catheters and this may expose you to the possibility of side-effects that you would not have been exposed to if you had the uroflowmetry assessment only (these are discussed in more detail under 'Assessment information' below.

The benefits of taking part are that you will be providing evidence for future men with bothersome LUTS who may be faced with this decision about diagnostic methods before surgery.

After your 18 months hospital appointment you will return to standard NHS care. However we would like to be able to contact you after this, with your permission. We would like to contact you again to a) check on your long-term health, for example by sending you other questionnaires to add information to what we already know about you, or by checking NHS medical records; and b) to ask you if you would like to take part in other relevant studies. You will not have to reply to any questionnaires or take part in other studies unless you want to at that time.

We hope that 800 men will take part in this study across the UK. Urologists will be informed of the recommendations from the study, so that in future all men can receive the best assessment available before deciding whether or not to have surgery for their bothersome LUTS. The results of the study will be published in scientific journals and a short version will also be available to you. No one will be able to identify you from any of the study reports.

This study is being funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA) (project number 12/140/01). The research is being carried out by a group of experienced doctors and researchers at each of the hospitals involved in this study. They are working in collaboration with researchers at the University of Bristol’s Bristol Randomised Trials Collaboration (BRTC), a fully registered Clinical Trials Unit.

South Central Oxford B Research Ethics Committee, your local hospital and your urology consultant have given approval for this study to be carried out. An independent Steering Committee and a Data Monitoring Committee monitor safety and ensure that the study is conducted in accordance with good research practice.

Taking part in this study does not affect your normal legal rights. Whether or not you do take part, you will retain the same legal rights as any other patient in the NHS (which includes professional indemnity insurance for negligence). If you wish to complain about your health care or any aspects of this study, the normal NHS mechanisms will be available to you. We do not expect participation to affect private medical insurance, but please check with your insurers before agreeing to take part in the study.

If you have a concern about any aspect of the study, you should ask to speak with the research team who will do their best to answer your questions (phone 0117 331 3907 / 0117 331 4519). If you are still concerned and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from your hospital. If you became unable or unwilling to continue in UPSTREAM, we will withdraw you from the study. We would retain, confidentially and with your consent, the relevant information that we had already collected about you, for the purposes of the study only. However, we will remove your personal data if you prefer.

Yes, all information collected for the study at any time will be stored using a Study Identity Number for confidentiality and will be kept secure using passwords. This includes the questionnaires that may be sent to you in the longer term as mentioned above. The information will only be available to the research team and the NHS or University bodies responsible for maintaining research standards. Your own doctor (GP) and consultant will be informed of your participation in the study.

In order to increase the usefulness of the whole study, we plan to confidentially link your answers with electronic data from your medical NHS records related to your health after your surgery. We will ask you for specific consent to this. Again this information will be kept secure and confidential. It is a requirement that your records in this research, together with any relevant medical records, can be looked at by monitors from the sponsors, the Research and Development Department of your local hospital or the Regulatory Authorities.

Their job is to check that research is properly conducted and the interests of those taking part are adequately protected. Other researchers may wish to access data from this study in the future: this will not include names, addresses or dates of birth, and it will not be possible to identify participants in any way. If this happens, the consultant leading the study will ensure that the other researchers comply with legal, data protection and ethical guidelines.

If you have any questions about the study, or any aspect of your treatment or health whilst on the study, please speak to your UPSTREAM research nurse or consultant or your own urology consultant or GP. Alternatively you can contact the UPSTREAM Study Office (email: UPSTREAM-trial@bristol.ac.uk, or telephone 0117 331 3907).

The aim of the UPSTREAM study is to compare a diagnostic pathway that does not have urodynamics with one which includes urodynamics as an additional assessment for men with bothersome lower urinary tract symptoms (LUTS). These diagnostic pathways provide the test results that are used when men and their Urologists decide whether surgery would be useful for their LUTS. We would like to see if the additional information provided by the urodynamics assessment helps urologists make more accurate decisions about whether surgery is likely to be helpful for a man’s LUTS.

You have been referred for diagnostic assessment of your LUTS with a view to making a decision about whether or not to have surgery.

If you take part in this study you will have the usual set of diagnostic assessments for LUTS at your hospital, including a test called uroflowmetry. Half of the men in the study will have an additional diagnostic test called urodynamics. We are interested in seeing if adding urodynamics to the diagnosis of men with LUTS is better than using uroflowmetry alone. Here, we will tell you about the two procedures and things you might expect. If you have any questions about this information, or about the procedures, your nurse or urologist will be happy to discuss them with you.

All of the men taking part in the study will have the usual physical examination and an assessment by uroflowmetry. Half of the men will then return for another appointment for assessment by urodynamics.

The uroflowmetry assessment

Uroflowmetry is a simple test to measure how much urine you pass, the strength of the flow and how efficiently your bladder empties. It involves urinating into a special container which measures the speed of your urination, after this an ultrasound probe will be passed over your lower abdomen which will measure how much urine you have left in your bladder.

The urodynamics assessment

A jelly will be introduced into your urethra (water pipe) to reduce sensation, and a fine tube will then be gently passed along your urethra until it reaches the bladder. Some men find the jelly gives a stinging sensation for about half a minute. Some men find the tube is uncomfortable as it is placed, but this discomfort settles quickly once the tube is in position. As part of assessing your symptoms, we need to evaluate your prostate gland. So, the doctor will use a gloved finger to feel the gland in the anus (back passage), and will leave a small tube in the anus. This tube will be used to measure pressure in your abdomen for the urodynamics test.

During the test, your bladder will be filled slowly with water. You will be asked to cough at intervals, and to tell us when you first feel the desire to pass urine (i.e. when you feel your bladder is getting full). When your bladder is full, you will be asked to pass urine, and the bladder pressure will be measured as you do so. Patients can find the test embarrassing but it provides the clinical team with important diagnostic information.

After your diagnostic assessment procedures are completed you will have an appointment to meet with your urologist who will talk you through the results. Your urologist will explain what the results mean and whether they indicate that surgery might help your symptoms.

All of the men who agree to take part in the study will be assessed by uroflowmetry. You will be asked to arrive for your appointment with a comfortably full bladder. It is possible there may be some discomfort associated with this for men with LUTS, if their bladder gets overfull. Half of the men taking part in the study will have a further diagnostic assessment with urodynamics. Most patients do not suffer any problems after they have had a urodynamics assessment, however the following side-effects are possible for some men:

Common (greater than 1 in 10)

• Temporary discomfort on passing urine
• Mildly bloodstained urine

Occasional (between 1 in 10 and 1 in 50)

• Urine infection
• Inability to pass urine, requiring a temporary catheter
• Inability to insert the catheter, requiring further investigation

Rare (less than 1 in 50)

• Failure to give a definitive diagnosis, sometimes requiring that the test be repeated.

The uroflowmetry assessment will provide information on how fast urine is being expelled from the bladder, and how much was passed. The ultrasound will then show how much urine is left in the bladder. The urodynamics test gives information on how the bladder is functioning, which might provide additional information about what is causing LUTS for a particular man. Urodynamics can show if the bladder muscle is over or underactive. If a man’s LUTS is caused by poor bladder muscle activity, rather than a blockage in the urethra, he may be less likely to experience an improvement in symptoms if he were to have an operation.

Uroflowmetry and urodynamics are regularly used for diagnosis for men with LUTS in the NHS. However, research has not been carried out to examine whether an assessment including urodynamics is better than uroflowmetry alone. In order to compare these diagnostic pathways fairly, we need to randomise men to one or the other by chance. If you take part in the trial you will be assigned to a group that has uroflowmetry alone or a group that has uroflowmetry and urodynamics by chance, like tossing a coin. If you choose not to take part in the trial, your symptoms will be assessed in the standard way at your hospital, and this may include uroflowmetry and urodynamics.

There are other assessments for men with LUTS but these may not be available at your hospital. You may be able to access other treatments at another hospital. Your nurse and urologist will tell you what choices are available to you, and you can discuss your options with your GP.