PMID- 32902375 OWN - NLM STAT- MEDLINE DCOM- 20210916 LR - 20210916 IS - 2046-4924 (Electronic) IS - 1366-5278 (Print) IS - 1366-5278 (Linking) VI - 24 IP - 42 DP - 2020 Sep TI - Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT. PG - 1-122 LID - 10.3310/hta24420 [doi] AB - BACKGROUND: Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery. OBJECTIVES: The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome. DESIGN: This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research. SETTING: Urology departments of 26 NHS hospitals in England. PARTICIPANTS: Men (aged >/= 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised. INTERVENTIONS: Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm). MAIN OUTCOME MEASURES: The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness. RESULTS: A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional pound216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS. LIMITATIONS: The trial met its predefined recruitment target, but surgery rates were lower than anticipated. CONCLUSIONS: Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS. FUTURE WORK: Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56164274. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information. FAU - Lewis, Amanda L AU - Lewis AL AUID- ORCID: 0000-0003-0488-5347 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Young, Grace J AU - Young GJ AUID- ORCID: 0000-0002-5210-1183 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Selman, Lucy E AU - Selman LE AUID- ORCID: 0000-0001-5747-2699 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Rice, Caoimhe AU - Rice C AUID- ORCID: 0000-0003-3017-2279 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Clement, Clare AU - Clement C AUID- ORCID: 0000-0002-5555-433X AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Ochieng, Cynthia A AU - Ochieng CA AUID- ORCID: 0000-0002-5574-6059 AD - Population Medicine, School of Medicine, Cardiff University, Cardiff, UK. FAU - Abrams, Paul AU - Abrams P AUID- ORCID: 0000-0003-2776-2200 AD - Bristol Urological Institute, Southmead Hospital, Bristol, UK. FAU - Blair, Peter S AU - Blair PS AUID- ORCID: 0000-0002-7832-8087 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Chapple, Christopher AU - Chapple C AUID- ORCID: 0000-0002-2960-9931 AD - Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. FAU - Glazener, Cathryn Ma AU - Glazener CM AUID- ORCID: 0000-0001-8667-2382 AD - Health Services Research Unit, University of Aberdeen, Aberdeen, UK. FAU - Horwood, Jeremy AU - Horwood J AUID- ORCID: 0000-0001-7092-4960 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - McGrath, John S AU - McGrath JS AUID- ORCID: 0000-0001-9416-9912 AD - University of Exeter Medical School, Exeter, UK. FAU - Noble, Sian AU - Noble S AUID- ORCID: 0000-0002-8011-0722 AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Taylor, Gordon T AU - Taylor GT AUID- ORCID: 0000-0002-8029-2503 AD - University of Plymouth, Plymouth, UK. FAU - Lane, J Athene AU - Lane JA AUID- ORCID: 0000-0002-7578-4925 AD - Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK. AD - Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. FAU - Drake, Marcus J AU - Drake MJ AUID- ORCID: 0000-0002-6230-2552 AD - Bristol Urological Institute, Southmead Hospital, Bristol, UK. LA - eng SI - ISRCTN/ISRCTN56164274 GR - MR/K025643/1/MRC_/Medical Research Council/United Kingdom GR - 12/140/01/DH_/Department of Health/United Kingdom PT - Journal Article PT - Multicenter Study PT - Pragmatic Clinical Trial PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Health Technol Assess JT - Health technology assessment (Winchester, England) JID - 9706284 SB - IM MH - Adult MH - Aged MH - *Cost-Benefit Analysis MH - England MH - Humans MH - *Lower Urinary Tract Symptoms/diagnosis/therapy MH - Male MH - Middle Aged MH - Patient Reported Outcome Measures MH - Quality-Adjusted Life Years MH - Surveys and Questionnaires MH - *Urinary Bladder Neck Obstruction/diagnosis/surgery MH - Urinary Bladder, Underactive/diagnosis MH - Urodynamics/*physiology MH - *Urologic Surgical Procedures, Male PMC - PMC7520720 OAB - After hospital referral, men with bothersome lower urinary tract symptoms (LUTS) are assessed with standard tests. These include measurement of urine flow rate, bladder diaries and questionnaires, including the International Prostate Symptom Score (IPSS). UPSTREAM (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods) researched whether or not including an extra test, urodynamics (UDS), helps when considering treatment options. UDS is a more invasive test and measures pressure in the bladder to check whether or not the prostate is causing obstruction. It was presumed that, if there is no obstruction, surgery would not be offered, so that using UDS would reduce the number of prostate operations. Each man participating (820 in total) was assessed with the standard tests. Around half of them had no extra tests (the 'routine care' arm of the trial); the rest had the UDS tests (the 'UDS' arm). Men then went on to have treatment, which they chose having discussed their test results with a urologist. IPSS and other symptom scores were examined for each man 18 months after joining the trial. At 18 months, surgery outcomes were known for 792 men and IPSS was known for 669 men. We investigated if the two trial arms showed similar changes in the IPSS and if there were fewer operations done in the UDS arm. We identified similar reductions in the IPSS in both arms. However, UDS tests did not reduce the number of operations. Analysing all the costs, it was found that a pathway including UDS costs more than routine care. Interviews were conducted that showed that men found UDS acceptable, and that the additional information helped both the men and their doctors consider which treatment would be most appropriate. These results do not support the routine use of UDS in the assessment of every man considering prostate surgery for LUTS. Further exploration of the data may identify circumstances in which UDS could be helpful. OABL- eng OTO - NOTNLM OT - BENIGN PROSTATIC OBSTRUCTION OT - BLADDER OUTLET OBSTRUCTION OT - COST-BENEFIT ANALYSIS OT - DETRUSOR OVERACTIVITY OT - DETRUSOR UNDERACTIVITY OT - DIAGNOSTIC TESTS (ROUTINE) OT - LOWER URINARY TRACT SYMPTOMS OT - PATIENT-REPORTED OUTCOME MEASURES OT - PROSTATE OT - QUALITATIVE RESEARCH OT - RANDOMISED CONTROLLED TRIAL OT - SURGERY OT - UNDERACTIVE BLADDER OT - UPSTREAM OT - URINARY BLADDER NECK OBSTRUCTION OT - URINARY RETENTION OT - URODYNAMICS OT - UROLOGIC SURGICAL PROCEDURES COIS- Outside this work, Paul Abrams reports grants and personal fees for being a consultant and speaker for Astellas Pharma Inc. (Tokyo, Japan), and personal fees for being a consultant for Ipsen (Paris, France) and a speaker for Pfizer Inc. (New York City, NY, USA) and Sun Pharmaceutical Industries Ltd (Mumbai, India). He also reports personal fees from Pierre Fabre S.A. (Paris, France) and Coloplast Ltd (Peterborough, UK). Christopher Chapple reports being an author for Allergan plc (Dublin, Ireland) and Astellas Pharma; being an investigator for scientific studies/trials with Astellas Pharma and Ipsen; being a patent holder with Symimetics; receiving personal fees as a consultant/advisor for Astellas Pharma, Bayer Schering Pharma GmbH (Berlin, Germany), Ferring Pharmaceuticals (Saint-Prex, Switzerland), Galvani Bioelectronics (GlaxoSmithKline; Stevenage, UK), Pierre Fabre, Symimetics, TARIS Biomedical Inc. (Lexington, MA, USA), and Urovant Sciences (Irvine, CA, USA); and receiving personal fees as a meeting participant/speaker for Astellas Pharma and Pfizer. J Athene Lane was a member of the Clinical Trials Unit funded by the National Institute for Health Research during the conduct of this trial. Marcus J Drake reports being on associated advisory boards and has received grants, personal fees and non-financial support from Allergan, Astellas Pharma and Ferring Pharmaceuticals. He has also received personal fees from Pfizer. EDAT- 2020/09/10 06:00 MHDA- 2021/09/18 06:00 PMCR- 2020/09/28 CRDT- 2020/09/09 12:23 PHST- 2020/09/09 12:23 [entrez] PHST- 2020/09/10 06:00 [pubmed] PHST- 2021/09/18 06:00 [medline] PHST- 2020/09/28 00:00 [pmc-release] AID - 10.3310/hta24420 [doi] PST - ppublish SO - Health Technol Assess. 2020 Sep;24(42):1-122. doi: 10.3310/hta24420.