Plain English Summary
Background and study aims
The prostate gland sits around the exit of the bladder in men. As men get older, the prostate grows, and this can narrow the exit from the bladder, so that there is restriction of flow. As a result, some men develop difficulty passing urine (voiding) as they age. For these men, prostate surgery can be helpful by removing the part of the prostate causing the narrowing, so that flow improves. However, for some men, almost identical symptoms of difficulty passing urine are due to underactive bladder. In other words, the bladder contraction is too weak, and is not effective at expelling the urine. This is a smaller group, but important, as these men may have no improvement after prostate surgery, while being exposed to risk of complications of surgery. Medical assessment of men with voiding problems typically involves discussing the symptoms, doing a physical examination of the prostate and measuring the urine flow rate. In many NHS hospitals, these are the only tests done before deciding whether to proceed to prostate surgery. In effect, voiding symptoms are presumed to be a result of prostate enlargement for these men, since it is the more common problem compared with bladder underactivity. However, this approach cannot identify which men actually have bladder underactivity as the cause of their voiding symptoms. So, in some hospitals an extra test is used, called urodynamics. Urodynamics is done to measure how much pressure the bladder generates when passing urine, because a high pressure shows the problem is obstruction, and a low pressure shows it is bladder weakness. Urodynamics involves gently putting a small tube into the bladder via the penis to measure the bladder pressure, and to fill the bladder with a sterile fluid (saline). Another small tube is gently placed into the rectum, via the anus, to measure abdominal pressures. Measuring abdominal pressure is necessary because any change in abdominal pressure can affect bladder pressure, and if the test did not allow for this it could give a misleading result. Urodynamics is safe, but some men find it uncomfortable or undignified, and a few develop urine infection afterwards. No studies have been conducted so far to tell us which of these two approaches to assessing men with voiding urinary problems is better overall.
Who can participate?
Men who have difficulty passing urine and who are considering having surgery for the symptoms can take part in the study.
What does the study involve?
If you take part in the study, you will be asked to complete a questionnaire and a bladder diary, you will do a flow rate test, and we will check your urine for infection during a hospital visit. You will be assigned at random to have the standard NHS tests either with or without urodynamics. If you are assigned to the urodynamics group, the test will be done at another hospital visit. You will then discuss the results with your urologist and you will decide whether to have surgery, based on the results of the test and the answers to any questions you have for your urologist. You will be asked to complete symptom questionnaires at 6, 12 and 18 months after joining the study. These will analyse your urinary symptoms, your quality of life, satisfaction with testing, sexual function and health outcomes. You will do a follow-up flow rate test (two flow rate tests if you have surgery). You may be asked to have an interview with a qualitative researcher to discuss your opinions in more detail. This study will compare the two methods of assessing symptoms by finding out whether the men had similar relief of their symptoms. We will also study whether the urodynamic tests changed the decision for surgery in some of the men (how many men had surgery in each of the two groups?). We will assess the cost-effectiveness of the two management pathways, and study any side effects of the tests and the treatments.
What are the possible benefits and risks of participating?
The information will be important for men trying to decide on management of their symptoms, for the doctors advising them, and for the NHS in ensuring the best use is made of resources for this common problem. Side effects of the treatment include urinary infection and urinary retention.
Where is the study run from?
The study is being run at the following hospitals in the UK: Southmead Hospital, Bristol with the Bristol Randomised Trial Centre. The research is also being done in Queen Elizabeth Hospital Birmingham, Epsom and St Helier NHS Trust, Royal Devon and Exeter Hospital, Kingston-upon-Thames, Leicester, Manchester, Freeman Hospital Newcastle, Churchill Hospital Oxford, Reading Hospital, Sheffield Hallam Hospital, Southport Hospital, and Taunton Hospital.
When is the study starting and how long is it expected to run for?
October 2014 to September 2017.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Mr Marcus Drake
Mr Marcus Drake
Bristol Urological Institute
+44 (0)117 323 5690
A randomised controlled trial to determine the clinical and cost effectiveness of invasive urodynamic studies for diagnosis and management of bladder outlet obstruction in men in the UK National Health Service (NHS)
In men with bothersome lower urinary tract symptoms (LUTS), we hypothesise that diagnostic categorisation of bladder outlet obstruction using invasive urodynamics improves patient selection for obstruction-relieving prostate surgery compared to a pathway with no invasive urodynamic testing. Consequently, this will make it less likely that the subgroup of men with LUTS who do not have bladder outlet obstruction will elect to undergo surgery, thereby reducing risk of harm from surgery and potentially worse symptom outcomes.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1214001
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/117886/PRO-12-140-01.pdf
NRES Committee South Central - Oxford B, 10/07/2014, REC ref: 14/SC/0237
Randomised controlled parallel-group trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Lower urinary tract symptoms; Urodynamics
A care pathway based on urodynamic tests with invasive multichannel cystometry ('invasive urodynamics' active intervention arm) and a care pathway based on non-invasive tests, i.e. without multichannel cystometry ('usual care' control arm).
Primary outcome measures
Difference in lower urinary tract symptom (LUTS) between the two arms at 18 months, measured with the International Prostate Symptom Score (IPSS)
Secondary outcome measures
1. Surgery rate (the relative proportion of men in each group having surgery up to 18 months after randomisation).
2. Cost-effectiveness analyses from the perspectives of the NHS, Personal Social Services and patients. Subsequent need for surgery will be recorded.
3. Adverse events of testing and treatment (e.g. infection, urinary retention).
4. Measures from the International Consultation on Incontinence Questionnaires (ICIQ) (Abrams et al., 2006) will be used alongside the IPSS, giving sensitive and comprehensive assessment of LUTS severity/ bother, sexual function, quality of life and satisfaction with urodynamic testing. The following will be measured at 6, 12 and 18 months;
4.2. ICIQ Male LUTS (ICIQ-MLUTS)
4.3. ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex)
4.4. ICIQ quality of life (ICIQ-QoL)
4.5. ICIQ urodynamics satisfaction (ICIQ-UDS-S) will be administered at a single time point after urodynamic testing for relevant patients.
5. Maximum urinary flow rate (Qmax) at 18 months. In men undergoing surgery in both arms, an additional Qmax measure at 4 months after operation will be used as a quality measure for surgery.
6. The EQ-5D-5L will be used to provide the quality of life weights used to calculate Quality Adjusted Life Years (QALYs).
7. Qualitative interviewing will explore user acceptability and influences on decisions made by the participating men and the surgeons.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Men considering undergoing surgery as a treatment option for their bothersome LUTS
2. Willing to be randomised
Target number of participants
Participant exclusion criteria
1. are unable to pass urine without a catheter (urinary retention)
2. have a relevant neurological disease
3. undergoing active treatment, or on active surveillance, for prostate or bladder cancer
4. have previously had prostate surgery
5. are not medically fit for surgery, or unable to complete outcome assessments
6. do not consent to be randomised
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Bristol Urological Institute
Southmead Hospital (UK)
c/o Helen Lewis
Research and Innovation Office
Floor 3 Learning and Research
+44 (0)117 323 6468
NIHR Health Technology Assessment Programme - HTA (UK); HTA 12/140/01
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26651344