Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Autor:	Worthington J; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Frost J; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Sanderson E; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Cochrane M; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Wheeler J; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Cotterill N; School of Health and Social Wellbeing, College of Health, Science and Society, University of the West of England, Bristol, UK., MacNeill SJ; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Noble S; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Avery M; School of Health Sciences, University of Southampton, Southampton, UK., Clarke S; Clinical Research Centre, Southmead Hospital, North Bristol NHS Trust, Bristol, UK., Fader M; School of Health Sciences, University of Southampton, Southampton, UK., Hashim H; Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK., McGeagh L; National Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust, University of Bristol, Bristol, UK., Macaulay M; School of Health Sciences, University of Southampton, Southampton, UK., Rees J; Tyntesfield Medical Group, Bristol, UK., Robles L; National Institute for Health and Care Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust, University of Bristol, Bristol, UK., Taylor G; Patient and public involvement representative, UK., Taylor J; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Thompson J; Clinical Research Centre, Southmead Hospital, North Bristol NHS Trust, Bristol, UK., Lane JA; Bristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Ridd MJ; Centre of Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Drake MJ; Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.; Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Jazyk:	angličtina
Zdroj:	Health technology assessment (Winchester, England) [Health Technol Assess] 2024 Mar; Vol. 28 (13), pp. 1-162.
DOI:	10.3310/GVBC3182
Abstrakt:	Background: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design: This was a two-arm cluster randomised controlled trial. Setting: The trial was set in 30 NHS general practice sites in England. Participants: Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions: Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main Outcome Measures: The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results: A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm ( n = 17) and 553 in sites randomised to the control arm ( n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of -£29.99, 95% confidence interval -£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval -0.011 to 0.014). Conclusions: The intervention showed a small, sustained benefit for men's lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial Registration: This trial is registered as ISRCTN11669964. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment ; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.
Databáze:	MEDLINE
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