TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

• DOI: 10.21203/rs.2.12511/v1
• Publication Date: 2019-08-08T01:45:41Z
• Authors: Jessica Frost; J Athene Lane; Nikki Cotterill; Mandy Fader; Lucy Hackshaw-McG...; Hashim Hashim; Margaret Macaulay; Stephanie J MacNeill; Sian Noble; Jonathan Rees; Matthew J Ridd; Luke Robles; Gordon Taylor; Jodi Taylor; Marcus Drake; Jo Worthington
• Keywords: Male; Medicine (General); TRIUMPH; BTC (Bristol Trials Centre); Study Protocol; 03 medical and health sciences; R5-920; 0302 clinical medicine; Lower Urinary Tract Symptoms; /dk/atira/pure/core/keywords/btc_brtc; name=BRTC; Outcome Assessment, Health Care; Cluster Analysis; Humans; Lower urinary tract symptoms; Centre for Health and Clinical Research; /dk/atira/pure/core/keywords/btc_bristol_trials_centre_; /dk/atira/pure/core/keywords/btc_brtc; Randomized Controlled Trials as Topic; International Prostate Symptom Score; Primary Health Care; /dk/atira/pure/core/keywords/btc_bristol_trials_centre_; name=BTC (Bristol Trials Centre); /dk/atira/pure/core/keywords/centre_for_surgical_research; name=Centre for Surgical Research; Primary care; 3. Good health; TRIUMPH, lower urinary tract symptoms, cluster randomised controlled trial, primary care, International Prostate Symptom Score.; Centre for Surgical Research; Health; Cluster randomised controlled trial; BRTC; Health & Wellbeing; /dk/atira/pure/core/keywords/centre_for_surgical_research

Abstract Background Lower urinary tract symptoms (LUTS) can relate to storage or voiding. In men, the prevalence and severity of LUTS increases with age, a significant impact on quality life. The majority men presenting are managed by their General Practitioner (GP) in first instance, conservative therapies recommended as initial treatment. However, provision primary care is variable be time resource limited. GPs require practical resources enhance patient engagement such interventions. TRIUMPH aims determine whether standardised manualised intervention delivered achieves superior symptomatic outcome for versus usual care. Methods 2-arm cluster randomised controlled trial (RCT) being conducted 30 National Health Service (NHS) Practices England. comprises advice booklet developed health professional (HCP) consultation. patients nurses/healthcare assistants following assessment symptoms. Patients directed relevant sections booklet, providing element intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. 1:1 either deliver pathway. patient-reported International Prostate Symptom Score (IPSS) at months post-consent outcome. Secondary outcomes include cost-effectiveness, reported LUTS, life, HCP acceptability experience Primary analyses will an intention-to-treat basis. Discussion It unclear male effectively using current approaches. This lead inappropriately referred secondary experiencing persistent therefore holds key effective treatment these men. intervention, through its approach, has been support GP practices delivering pragmatic RCT robust evidence setting inform future guidelines.