Amanda L Lewis1, Grace J Young1, Paul Abrams2, Peter S Blair1, Christopher Chapple3, Cathryn M A Glazener4, Jeremy Horwood1, John S McGrath5, Sian Noble6, Gordon T Taylor7, Hiroki Ito2, Mohammed Belal8, Melissa C Davies9, Andrew J Dickinson10, Charlotte L Foley11, Steve Foley12, Simon Fulford13, Mohsen M Gammal14, Mary Garthwaite13, Mark R E Harris15, Petre C Ilie16, Robert Jones17, Samer Sabbagh18, Robert G Mason19, Ester McLarty10, Vibhash Mishra20, Jaswant Mom21, Roland Morley22, Salvatore Natale10, Tharani Nitkunan23, Tobias Page24, David Payne25, Tina G Rashid22, Kasra Saeb-Parsy26, Sarb S Sandhu27, Adrian Simoes28, Gurpreet Singh14, Mark Sullivan29, Heidi V Tempest29, Srinivasa Viswanath30, Roger M H Walker23, J Athene Lane1, Marcus J Drake31. 1. Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, Canynge Hall, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, Canynge Hall, University of Bristol, Bristol, UK. 2. Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. 3. Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Sheffield, UK. 4. Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, Scotland, UK. 5. University of Exeter Medical School, St. Luke's Campus, Exeter, UK. 6. Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK. 7. University of Plymouth, Plymouth, Devon, UK. 8. University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, UK. 9. Salisbury NHS Foundation Trust, Salisbury District Hospital, Salisbury, Wiltshire, UK. 10. Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth, UK. 11. East and North Hertfordshire NHS Trust, Urology Department, Ashwell Block, Lister Hospital, Stevenage, Hertfordshire, UK. 12. Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, Berkshire, UK. 13. South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK. 14. Southport and Ormskirk Hospital NHS Trust, Southport, Merseyside, UK. 15. University Hospital Southampton NHS Foundation Trust, Southampton, UK. 16. The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, King's Lynn, UK. 17. Urology Department, Taunton and Somerset NHS Foundation Trust, Musgrove Park Hospital, Taunton, Somerset, UK. 18. St George's University Hospitals NHS Foundation Trust, Tooting, London, UK. 19. Torbay and South Devon NHS Foundation Trust, Torbay Hospital, Torquay, UK. 20. Royal Free London NHS Foundation Trust, Royal Free Hospital, London, UK. 21. North Cumbria University Hospitals NHS Trust, West Cumberland Hospital, Hensingham, Whitehaven, Cumbria, UK. 22. Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK. 23. Epsom and St Helier University Hospitals NHS Trust, Carshalton, Surrey, UK. 24. The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, High Heaton, Newcastle Upon Tyne, UK. 25. Kettering General Hospital NHS Foundation Trust, Kettering, Northants, UK. 26. Urology Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. 27. Kingston Hospital NHS Foundation Trust, Surrey, UK. 28. East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, Kent, UK. 29. Nuffield Department of Surgical Sciences, Oxford University, Headington, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Headington, Oxford, UK. 30. Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. 31. Bristol Urological Institute, Level 3, Learning and Research Building, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.
Abstract
BACKGROUND: Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). OBJECTIVE: To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included. DESIGN, SETTING, AND PARTICIPANTS: A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. INTERVENTION: Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick's test, and questionnaire items were compared using Pearson's correlation coefficient. RESULTS AND LIMITATIONS: Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. CONCLUSIONS: Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. PATIENT SUMMARY: We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.
RCT Entities:
BACKGROUND: Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). OBJECTIVE: To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included. DESIGN, SETTING, AND PARTICIPANTS: A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. INTERVENTION: Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick's test, and questionnaire items were compared using Pearson's correlation coefficient. RESULTS AND LIMITATIONS: Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. CONCLUSIONS:Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. PATIENT SUMMARY: We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.
Authors: Amanda L Lewis; Grace J Young; Lucy E Selman; Caoimhe Rice; Clare Clement; Cynthia A Ochieng; Paul Abrams; Peter S Blair; Christopher Chapple; Cathryn Ma Glazener; Jeremy Horwood; John S McGrath; Sian Noble; Gordon T Taylor; J Athene Lane; Marcus J Drake Journal: Health Technol Assess Date: 2020-09 Impact factor: 4.014