Urodynamics for male lower urinary tract symptoms Review of the UPSTREAM study Prof. Marcus Drake Bristol Randomised Trial Centre University of Bristol (GB)
Marcus.Drake@ bristol.ac.uk
Dr. Amanda Lewis Bristol Randomised Trial Centre University of Bristol (GB)
amanda.lewis@ bristol.ac.uk For men who remain bothered by voiding symptoms despite initial treatment, surgery to relieve bladder outlet obstruction (BOO) is commonly considered. Urodynamics (UDS) aims to decide whether an individual would realistically benefit from such surgery, by diagnosing BOO formally, and looking for risk factors for bad outcome. For example, detrusor underactivity during voiding (DUA) may mean that symptoms will not improve even if BOO is treated. Alternatively, detrusor overactivity (DO) during storage might cause subsequent problems such as incontinence. Value of urodynamics Until recently, it was not clear whether urodynamics truly made a difference to outcomes beyond influencing clinical decision making1. Hence there was a split of opinions among urologists2. Some supported routine use of urodynamics, feeling that surgery to relieve BOO risks bringing more harm than benefit if BOO is not present. In contrast, supporters of selective use of urodynamics point to the lack of evidence, and the costs of providing the service. There was also a presumption about what the patients wanted, with an assumption that undergoing the test would not be popular. UPSTREAM UPSTREAM (Urodynamics for Prostate Surgery: Randomised Evaluation of Assessment Methods) is a randomised controlled trial (ISRCTN56164274) in men with bothersome lower urinary tract symptoms (LUTS), in whom surgery was an option3. Participants were randomised to either routine care (RC) diagnostic tests including uroflowmetry, symptom score and bladder diary or RC plus urodynamics (UDS). 820 men were randomised in 26 hospitals in England. The primary outcome was the International Prostate Symptom Score (IPSS) 18 months after randomisation. The UDS arm demonstrated noninferiority relative to RC, with a difference in the mean IPSS of 0.33. Overall IPSS fell from 19 to 13 in both arms. The median BOO index for the UDS arm was 48 and DO was seen in around half of the men4.
It is vital, however, that urologists understand some key points: • Any indication of neurological disease or a condition that increases the prevalence of DUA (such as diabetes mellitus) makes UDS an important test; • Individual choice by the patient may justify the use of UDS; • Some men suffered a deterioration in symptoms as a result of surgery. The UPSTREAM team is evaluating this further to derive predictors of outcome, and that work will yield the individual patient clinical indications for UDS; • It is essential to consider what type of LUTS the man is experiencing. To have a good chance of benefit from surgery, voiding LUTS must be present, and they should also be causing a substantial degree of bother. If storage LUTS are the principal cause of bad quality of life, outcome of BOO surgery is not good. ICIQ-MLUTS Alongside the IPSS, the study used the International Consultation on Incontinence Questionnaire (ICIQ). The additional information that this brings compared with only IPSS turned out to be very influential for understanding the quality of life impact of LUTS5. In particular, ICIQ-MLUTS measures the presence of dribble and incontinence, which are absent from the IPSS. Furthermore, it reports the bother associated with each individual symptom. Overall, this symptom score provided a quick and efficient way to capture which symptoms are present and bothersome. It is thus more valuable than IPSS in prioritising the therapy for an individual patient. Quality of testing The study was careful to ensure proper quality of testing, joining the UNBLOCS study6 in reviewing standards of flow rate testing and urodynamics for a proportion of tests during the set-up phase of the studies7. We identified wrongly-diagnosed BOO in 6%, which has to be considered a serious error since it could lead to unnecessary surgery being done. We also found that 28% of urodynamic centres did not record calibration checks and equipment servicing, meaning that the equipment may not measure accurately. Furthermore, centres sometimes failed to identify a potential recording problem at the crucial moment of maximum flow rate. This is crucial, since the tracing has to be scrutinised to make sure the correct data is used when diagnosing BOO [see Fig. 1]. Hence, centres were at risk of making an error of diagnosis, and again this could place the patient at risk of inappropriate surgery.
“…UDS did not actually reduce surgery rates” Effect on surgery rate The study looked to see whether UDS reduced the surgery rates, arguing that DUA could be identified with this additional test, and that this would mean the men would not undergo surgery to relieve BOO. 38% (153/408) in the UDS arm received surgery during the 18-month-period, compared with 36% (138/384) in the routine care arm. Hence it was clear that UDS did not actually reduce surgery rates. Conclusion The basic conclusion of the USPTREAM study is that UDS was non-inferior to RC for the IPSS but did not reduce surgical rates in this population. Hence, routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively3.
EAU Section of Female and Functional Urology
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European Urology Today
Fig. 1: A spike is present on the flow trace (red arrow). The machine interpreted this as being the patient’s maximum flow rate, and so erroneously derived the bladder outlet obstruction index from here. In fact, such spikes are not generated by bladder contraction, and the patient’s actual function is best indicated by the peak of the phasic flow curve (purple arrow). This is the point where the index should have been calculated.
Additional study results Extensive qualitative research was undertaken, and this established that Urodynamics is acceptable to men with LUTS and generally well tolerated8, in contrast to the clinicians’ generally held assumptions. We found evidence of clinicians and patients negotiating treatment decisions between them and of patients disagreeing with clinicians’ recommendations9. We also identified that consultations were sometimes rushed, with incomplete discussions of test results and treatment options, as well as misperceptions about LUTS and its treatment. Hence there is some need for units to
evaluate the service delivery in this area, which is a crucial component of any urology service. It is increasingly clear that men prefer conservative and less risky treatment options, but the preference varies depending on baseline symptom severity and the risk/benefit characteristics of the treatment. Men prefer reducing the risk of surgery1, and hence the role of UDS in potentially achieving this is valuable for individual patients. However, UPSTREAM found that UDS does not reduce surgery rates overall, and hence it should not be routine practice in otherwise healthy men with voiding LUTS. Over the next few years, the study will continue to report features to optimise the diagnostic pathway for LUTS in men. Acknowledgement This project was funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 12/140/01). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. This study was designed and delivered in collaboration with the BRTC, a UKCRC Registered Clinical Trials Unit (CTU), which, as part of the Bristol Trials Centre (BTC), is in receipt of NIHR CTU support funding. The UPSTREAM trial was sponsored by North Bristol NHS Trust (NBT), Bristol, UK. Study data were collected and managed using REDCap (Research Electronic Data Capture, Harris PA, et al. J Biomed Inform. 2009 Apr;42(2):377-81) hosted at the University of Bristol. References 1. Clement KD, Burden H, Warren K, Lapitan MCM, Omar MI, Drake MJ. Invasive urodynamic studies for the management of lower urinary tract symptoms (LUTS) in men with voiding dysfunction. Cochrane Database of Systematic Reviews: John Wiley & Sons, Ltd; 2015. 2. Drake MJ, Lewis AL, Lane JA. Urodynamic Testing for Men with Voiding Symptoms Considering Interventional Therapy: The Merits of a Properly Constructed Randomised Trial. Eur Urol. 2016;69(5):759-60.
3. Drake MJ, Lewis AL, Young GJ, Abrams P, Blair PS, Chapple C, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol. 2020;78(5):701-10. 4. Lewis AL, Young GJ, Abrams P, Blair PS, Chapple C, Glazener CMA, et al. Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). Eur Urol Focus. 2019;5(3):340-50. 5. Ito H, Young G, Lewis A, Blair PS, Cotterill N, Lane A, et al. Grading severity and bother using the IPSS and ICIQ-MLUTS scores in men seeking lower urinary tract symptoms therapy. Journal of Urology. 2020. 6. Hashim H, Worthington J, Abrams P, Young G, Taylor H, Noble SM, et al. Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial. Lancet. 2020;396(10243):50-61. 7. Aiello M, Jelski J, Lewis A, Worthington J, McDonald C, Abrams P, et al. Quality control of uroflowmetry and urodynamic data from two large multicenter studies of male lower urinary tract symptoms. Neurourol Urodyn. 2020;39(4):1170-7. 8. Selman LE, Ochieng CA, Lewis AL, Drake MJ, Horwood J. Recommendations for conducting invasive urodynamics for men with lower urinary tract symptoms: Qualitative interview findings from a large randomized controlled trial (UPSTREAM). Neurourol Urodyn. 2019;38(1):320-9. 9. Selman LE, Clement C, Ochieng CA, Lewis AL, Chapple C, Abrams P, et al. Treatment decision-making among men with lower urinary tract symptoms: A qualitative study of men's experiences with recommendations for patient-centred practice. Neurourol Urodyn. 2021;40(1):201-10. 10. Malde S, Umbach R, Wheeler JR, Lytvyn L, Cornu JN, Gacci M, et al. A Systematic Review of Patients' Values, Preferences, and Expectations for the Diagnosis and Treatment of Male Lower Urinary Tract Symptoms. Eur Urol. 2021.
EAU21 Industry Sessions Thursday, 8 July
Friday, 9 July
12.00 - 13.00 Intuitive 19.00 - 20.00 Boston Scientific 19.00 - 20.00 Laborie
12.45 - 13.45 12.45 - 13.45 18.00 - 19.00 18.00 - 19.00
Saturday, 10 July
Sunday, 11 July
09.30 - 10.30 09.30 - 10.30 14.15 - 15.15 14.15 - 15.15 18.30 - 19.30
10.15 - 11.15 10.15 - 11.15 14.00 - 15.00 18.00 - 19.00 18.00 - 18.30
Ipsen MedscapeLive Bristol-Myers Squibb IBSA Astellas
Astellas Janssen AstraZeneca GSK
Astellas Pierre Fabre Bayer Bio Techne Recordati
This overview of the Industry Sessions planned during EAU21 Virtual, 8-12 July 2021 is tentative and subject to be changed. For the latest and most up-to-date programme, visit eau2021.org.
March/May 2021
