title: Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Lower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS.
  
  
  METHODS
  A 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome.
  
  
  CONCLUSIONS
  The general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction.
  
  
  BACKGROUND
  Controlled-trials.com - ISRCTN56164274 (confirmed registration: 8 April 2014).
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. K.bailey@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. K.bailey@bristol.ac.uk.
authors.forename: K
authors.initials: K
authors.lastname: Bailey
authors.affiliation: North Bristol NHS Trust, Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, Bristol, BS10 5N, UK. paul.abrams@bui.ac.uk.
authors.forename: P
authors.initials: P
authors.lastname: Abrams
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. p.s.blair@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. p.s.blair@bristol.ac.uk.|Bristol Randomised Trials Collaboration, University of Bristol, St. Michael's Hospital, Level D, Southwell Street, Bristol, UK. p.s.blair@bristol.ac.uk.
authors.forename: P S
authors.initials: PS
authors.lastname: Blair
authors.affiliation: Sheffield Teaching Hospitals NHS Trust, Room H26, H-Floor, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK. c.r.chapple@sheffield.ac.uk.
authors.forename: C
authors.initials: C
authors.lastname: Chapple
authors.affiliation: Health Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, Scotland. c.glazener@abdn.ac.uk.
authors.forename: C
authors.initials: C
authors.lastname: Glazener
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. j.horwood@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. j.horwood@bristol.ac.uk.
authors.forename: J
authors.initials: J
authors.lastname: Horwood
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. athene.lane@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. athene.lane@bristol.ac.uk.
authors.forename: J A
authors.initials: JA
authors.lastname: Lane
authors.affiliation: Exeter Surgical Health Services Research Unit - Urology, Royal Devon and Exeter Hospital, Barrack Road, Exeter, Devon, EX2 5DW, UK. john.mcgrath4@nhs.net.
authors.forename: J
authors.initials: J
authors.lastname: McGrath
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. s.m.noble@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. s.m.noble@bristol.ac.uk.
authors.forename: S
authors.initials: S
authors.lastname: Noble
authors.affiliation: Institute of Cellular Medicine, University of Newcastle, 3rd Floor, William Leech Building, Newcastle upon Tyne, NE2 4HH, UK. robert.pickard@newcastle.ac.uk.
authors.forename: R
authors.initials: R
authors.lastname: Pickard
authors.affiliation: University of Plymouth, Plymouth, Devon, PL4 8AA, UK. anythingyoulike@btinternet.com.
authors.forename: G
authors.initials: G
authors.lastname: Taylor
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. grace.young@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. grace.young@bristol.ac.uk.
authors.forename: G J
authors.initials: GJ
authors.lastname: Young
authors.affiliation: North Bristol NHS Trust, Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, Bristol, BS10 5N, UK. marcus.drake@bristol.ac.uk.|School of Clinical Sciences, University of Bristol, 69 St Michael's Hill, BS2 8DZ, Bristol, UK. marcus.drake@bristol.ac.uk.
authors.forename: M J
authors.initials: MJ
authors.lastname: Drake
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. amanda.lewis@bristol.ac.uk.|Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. amanda.lewis@bristol.ac.uk.
authors.forename: A L
authors.initials: AL
authors.lastname: Lewis
mesh_terms: D002985:Clinical Protocols; D003937:Diagnosis, Differential; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000175:diagnosis* / Q000209:etiology / Q000503:physiopathology / Q000601:surgery; D008297:Male; D011237:Predictive Value of Tests; D011379:Prognosis; D011468:Prostatectomy; D011470:Prostatic Hyperplasia / Q000150:complications / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D006113:United Kingdom; D019564:Unnecessary Procedures; D001748:Urinary Bladder Neck Obstruction / Q000175:diagnosis* / Q000209:etiology / Q000503:physiopathology / Q000601:surgery; D014563:Urodynamics