Objective To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. Design Cluster randomised controlled trial. Setting 30 National Health Service general practice sites in England. Participants Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites). Intervention Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. Main outcome measures The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores. Results Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference −1.81 points, 95% confidence interval −2.66 to −0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. Conclusions A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of −1.81 points (95% confidence interval −0.95 to −2.66) on the IPSS was less than the predefined target reduction of 2.0 points. Trial registration ISRCTN Registry [ISRCTN11669964][1]. All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN11669964

中文翻译：

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使用保守干预治疗初级保健男性下尿路症状：整群随机对照试验

目的 确定与常规护理相比，在初级护理中对男性进行标准化和手动护理干预是否可以更好地改善下尿路症状 (LUTS)。设计集群随机对照试验。在英格兰设立 30 个国家医疗服务全科诊所。参与者地点按 1:1 随机分配到干预组和对照组。2018 年 6 月至 2019 年 8 月期间招募了 1077 名患有令人烦恼的 LUTS 的男性（≥18 岁）：524 名被分配到干预组（n = 17 个地点），553 名被分配到常规护理组（n = 13 个地点）。干预 根据患者和专家的意见制定的标准化信息手册，为男性 LUTS 的保守和生活方式干预提供指导。在评估泌尿系统症状（手册元素）后，全科护士和医疗保健助理或研究护士指导参与者阅读手册的相关部分，并在 12 周内提供联系以帮助其遵守。主要结果指标 主要结果是患者报告的国际前列腺症状评分 (IPSS)，在参与者同意参加研究后 12 个月进行测量。该研究的目标降低 2.0 分反映了基线 IPSS <20 的最小临床重要差异。次要结局是患者报告的生活质量、泌尿系统症状和 LUTS 感知、医院转诊和不良事件。主要意向治疗分析包括 887 名参与者（占招募参与者的 82%），并使用混合效应多级线性回归模型，并针对随机化和基线评分中使用的位点水平变量进行了调整。结果 干预组的参与者在 12 个月时的平均 IPSS 较低（调整后平均差 -1.81 点，95% 置信区间 -2.66 至 -0.95），表明泌尿系统症状比常规护理组的参与者要轻。12 个月时，干预组的 LUTS 特定生活质量、失禁和 LUTS 感知也比常规护理组改善更多。泌尿科转诊比例（干预 7.3%，常规护理 7.9%）和不良事件（干预 7 起事件，常规护理 8 起事件）在各组之间具有可比性。结论 初级保健中的标准化和手动干预显示，12 个月时男性 LUTS 持续减少。IPSS 的平均差异为 -1.81 分（95% 置信区间 -0.95 至 -2.66），小于预定目标减少 2.0 分。试用注册 ISRCTN 注册中心 [ISRCTN11669964][1]。所有数据请求均应提交给相应作者以供考虑。经过审查后可能会授予对匿名数据的访问权限。[1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN11669964