Clinical trial to assess effectiveness of urological tests in men who have difficulty passing urine
Tuesday, 17 March 2015
For the first time ever, a major new clinical trial, led by the Bristol Urological Institute at Southmead Hospital Bristol, aims to assess the clinical and cost effectiveness of urological tests in men who have difficulty passing urine.
As they get older, some men develop problems and difficulties passing urine. This may be for a number of reasons including an enlarged prostate gland – which narrows the bladder outlet (urethra), or because the bladder becomes less able to contract.
Prostate surgery is more likely to help symptoms in the first group of patients, while the second group may have no improvement after surgery and this could be wrong for them due to risk of complications including incontinence.
Urodynamics involves putting a small tube (catheter) into the bladder via the penis, and another into the rectum, to measure bladder and abdominal pressures while the bladder is filled with a sterile fluid.
The procedure is considered safe, but some men find it uncomfortable or undignified, and a few develop urine infection afterwards. Urodynamics can measure some aspects of bladder function, such as bladder pressures during filling and voiding, and bladder outlet obstruction pressures.
Consultant Urologist Marcus Drake, who will lead the trial, said: “We think that it could be useful to select the men who should and should not have surgery. However, no studies have been conducted so far to tell us if this is true. This study is designed to find out if the invasive tests are worthwhile.
“UPSTREAM is a randomised controlled trial in men who have bothersome difficulty passing urine and who are considering having surgery for their symptoms.”
Men who are willing and eligible to take part will be asked to complete routine assessments which includes a bladder diary and questionnaires which provides a measure of the relevant symptoms, have a physical examination, carry out flow rate testing and their urine will be tested for infection. Half of the men will also have the Urodynamics test. After all the tests are done, the urologist will review them, and the men will decide what treatment they then wish to have.
The study will be run in urology departments of at least 19 NHS hospitals.
The group studied will be men who continue to be bothered by difficulty passing urine, despite initial treatment such as drugs, and who are seeking further treatment, for example surgery.
Men will not be invited to take part if they:
• Are unable to pass urine without a catheter (urinary retention)
• Have a relevant neurological disease, such as a stroke
• Are undergoing treatment for prostate or bladder cancer
• Have previously had prostate surgery
• Are not medically fit for surgery, or are unable to complete outcome assessments
• Do not consent to be assigned at random to one of the pathways
Mr Drake added: “We will compare the two methods of investigation by finding out whether the men had similar relief of their symptoms, by measuring the change in the prostate symptom score in the two groups at 18 months after randomisation.
“We will also look at whether the Urodynamics tests changed the decision for surgery in some of the men, the cost effectiveness of the two pathways and urinary symptoms and quality life at various intervals.”
The four-year study will comprise a setting-up phase of six months, 18-months recruitment, 18-months follow-up and six months data analysis and communication of results.
The UPSTREAM team based at the University of Bristol’s Bristol Randomised Trials Collaboration (BRTC), within the School of Social and Community Medicine, will be responsible for the day-to-day management of study activities. They will provide overall methodological support for the design, conduct and analysis of the study.
The study will be supported by an independent Trial Steering Committee, a Patient Involvement Panel and a Data Monitoring Committee. 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 best use is made of resources for this common problem.
This project was funded by the National Institute for Health Research HTA programme (project number 12/140/01).
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.
You can keep up to date with the trial’s progress on Twitter (@UPSTREAM_trial) or the website http://www.bristol.ac.uk/social-community-medicine/projects/upstream/
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This article presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.