Tag: Trial

In a recently published qualitative study, we found that urodynamic testing was acceptable to men with lower urinary tract symptoms (LUTS), despite some reporting apprehension, discomfort or embarrassment and, at times, inadequate provision of information. Men’s experiences of urodynamics highlight ways in which clinical practice can be improved, including better communication about what to expect during and after the test, minimising embarrassment by ensuring privacy, and timely discussion of test results in sufficient detail.

Ninety percent of men aged 50‐80 live with at least one LUTS, which can negatively impact quality of life. LUTS prevalence and severity increase with age, and with demographic aging the management of LUTS is an increasing priority. Urodynamics with invasive multichannel cystometry is widely used when medications haven’t successfully relieved symptoms and surgery for bladder outlet obstruction is being considered. But there is ongoing debate about the extent to which urodynamics should be used, reflecting lack of evidence regarding the effectiveness of urodynamics and how acceptable it is to patients.

What we did

The Urodynamics for Prostate Surgery: Randomised Evaluation of Assessment Methods (UPSTREAM) randomised controlled trial is a 4-year study funded by the National Institute of Health Research Health Technology Assessment Programme (UK). The trial randomised 820 men with LUTS from urology departments in 26 hospitals in England to either a care pathway consisting of non-invasive routine tests, or one of routine tests plus urodynamics. At 18-months after randomisation, UPSTREAM assessed the effect of urodynamics on symptoms and rates of surgery in men with bothersome LUTS seeking further treatment.

In a large qualitative study nested within the UPSTREAM trial, we explored men’s attitudes to and experiences of urodynamics, to provide in‐depth qualitative evidence to inform clinical practice. We interviewed a diverse group of 41 men with LUTS, including those who had had urodynamics and those who had not.

What we found

All 25 men who underwent urodynamics reported that it was acceptable.
Of the 16 men who had not had urodynamics previously, 14 said they would have been willing to have it if needed (with four reporting some apprehension), while two said they would want more information about the test and its purpose.
Among patients who had had urodynamics, the test was well-tolerated, although there was variation in how uncomfortable men found it. Some men experienced short-lived negative after-effects (e.g. stinging, a urinary tract infection), but despite these issues said they would willingly have the test again.
A minority of men reported embarrassment, due to the intimate nature of urodynamics or not being prepared for its effects (e.g. spraying while urinating).
Embarrassment also depended on the degree of privacy available, including the number of people in the room during the test, room location and size (a larger room near a busy corridor was more socially awkward).
Patients valued urodynamics for its diagnostic insight, perceiving it as more informative than other tests. Patients felt that having urodynamics meant they had received all the investigative tests available and so had all possible facts regarding their condition.
Patients described gaps in the information provided by clinicians before, during, and after the test; for example, what to expect when the test was conducted and what the test results meant.
How and when results were explained varied: explanations were given during the test by the technician or nurse undertaking it, from a doctor straight after receiving the test, or at a separate appointment with a doctor a short time later. Men appreciated it when test results were available and discussed with a clinician immediately after the test.
While most men were satisfied with clinicians’ explanation of the results of urodynamics, this was not universal; rushed explanations were highlighted as problematic.

Recommendations

Based on men’s experiences, we recommend:

Good communication before and during the procedure, in line with patient preferences, to ensure patients are well prepared and informed.
Prioritising patient privacy, including minimising the number of people present during the test and introducing the staff members who are present.
Discussing test results with patients promptly, in the amount of detail they wish.
Training and guidance for urology clinicians and urodynamics technicians in these areas.

Acknowledgements

We acknowledge and thank the patients and clinicians involved in the UPSTREAM trial as well as the NHS trusts involved. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) program (project number 12/140/01). This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research CTU support funding. The views and opinions expressed are those of the authors and not necessarily those of the HTA program, NIHR, NHS, or the Department of Health and Social Care.

About the authors:

Dr Selman and Dr Horwood are Senior Research Fellows at University of Bristol, specialising in qualitative research in randomised trials. Twitter: @Lucy_Selman, @JPHorwood

Prof Drake is Professor of Physiological Urology at Bristol Urological Institute, North Bristol NHS Trust, and at Translational Health Sciences, Bristol Medical School, University of Bristol. Twitter: @MarcusDrakeUrol, @UroweESU

Dr Amanda Lewis is a Clinical Trial Manager at the University of Bristol, currently working in the area of Urology research. Twitter: @ALBrooks2015

The BJUI supports clinical trials. Plain, simple, and with some new strategies.

Randomised clinical trials (RCTs) are the highest level of evidence-based medicine. We know this to be true, but we also know that RCTs are a challenge to fund, accrue patients, execute, and follow to endpoints. From a statistician’s point of view, RCTs provide unbiased estimates of the effects of different treatments. From a clinician’s point of view, RCTs provide the grandest of experiments in nature – a true test of option A vs option B. We are thrilled when one option beats the other. We can be satisfied if the options are equivalent, at least knowing the matter is settled and move on to the next question. Either way, the story lines can be rich with ongoing debate, drama, and analysis: were the cohorts truly equivalent? Was the study population generalisable? Were the treatments contemporary? Were there unintended harms/toxicities?

Allow us to illustrate some examples of what we propose to our readers. In 2003, Thompson et al. [1] published the famous Prostate Cancer Prevention Trial in the New England Journal of Medicine: ‘The influence of finasteride on the development of prostate cancer’. This landmark study has been cited 2541 times, according to Google Scholar. Looking further at impact, one can go to the www.swog.org site and query the protocol ‘SWOG-9217’ and see that over 150 publications have been produced using this dataset (16 in 2016!). Several publications pre-dated the primary endpoint paper and discussed trial design, the dilemma of chemoprevention, and updates to trial progress. Post primary endpoint, publications have looked at multiple strategies – costs, the high-grade findings, longer-term follow-up, biopsy findings from the placebo arm, etc. Just last year, the UK made its mark on the prostate cancer world with the landmark Prostate Testing for Cancer and Treatment (ProtecT) study [2]. Again, we see the primary endpoint paper in the New England Journal of Medicine, but secondary endpoint papers, such as the quality-of-life outcomes are in the BJUI [3], and a mortality outcome analysis for trial screen failures in European Urology [4].

The BJUI can support clinical trial efforts through multiple pathways. Certainly, we would love to receive a primary endpoint paper from an important RCT in urology. We can also have impact by featuring important secondary endpoint papers, trial design papers (preferably ones that read like a good review article, with the trial proposed as the ‘answer’ to the dilemma), as well as smaller/early phase I–II trials that are stand-alone pieces of key knowledge. Figure 1 shows a possible flow chart of a RCT with each box representing possible publication points. In addition to content in the BJUI, our webpage Blogs section has a ‘rapid response team’ to start immediate dialogue on important RCTs published in other journals. For example with the recent Yaxley et al. [5] trial in the Lancet, our blogs section, led by Declan Murphy, had over 10 000 views and over 50 follow-up comments. So clearly, our readers care about RCTs.

Figure 1. A possible flow chart of a randomised clinical trial (RCT) with each box representing possible publication points. QOL, quality of life; f/u, follow-up.

Finally, the BJUI can help with RCTs in two more ways. For the reader, we will highlight RCT-related papers in their native sections (i.e. oncology, functional, education) with a special ‘Trials’ headline, and will invite experts to comment on the significance of the study. For reviewers and authors, we will be critical on RCT design, such that flaws are identified, and papers not given inflated significance. It is frustrating to receive papers that lack adequate reporting on what researchers did, RCT-related papers submitted to the BJUI frequently fail to adhere to the 2010 Consolidated Standards of Reporting Trials (CONSORT) guidance for reporting RCTs, which potentially leads to major revisions, if not outright rejection. The CONSORT requirements are on our author submission guidelines, but ideally these are read and adhered to in advance, as many are not possible to correct after the fact. Recently, we have also added that all RCTs must be registered (i.e. clinicaltrials.gov or similar) before the first patient is enrolled.

John W. Davis, Associate Editor, Urological Oncology* and

Graeme MacLennan, Consulting Editor, Statistics and Trials†

*MD Anderson Cancer Center, Houston, TX, USA and †University of Aberdeen, Aberdeen, UK

References

1 Thompson IM, Goodman PJ, Tangen CM et al. The inﬂuence of ﬁnasteride on the development of prostate cancer. N Engl J Med 2003; 349: 215–24

2 Donovan JL, Hamdy FC, Lane A et al. Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016; 375: 1425–37

3 Lane A, Metcalfe C, Young GJ et al. Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. BJU Int 2016; 118: 869–79

4 Johnston TJ, Shaw GL, Lamb AD et al. Mortality among men with advanced prostate cancer excluded from the ProtecT trial. Eur Urol 2017; 71: 381–8

5 Yaxley JW, Coughlin GD, Chambers SK et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016; 388: 1057–66

How to Cite this article

Davis, J. W. and MacLennan, G. (2017), The BJUI‘s clinical trials initiative. BJU International, 119: 503. doi: 10.1111/bju.13837

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Urodynamics is acceptable and well-tolerated but best practice is not always provided: lessons from male patients interviewed during the UPSTREAM trial

April Editorial: The BJUI’s clinical trials initiative

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