Prevention of urinary stones with hydration: a randomised clinical trial of an adherence intervention.

The effectiveness of interventions to maintain high fluid intake has not been well studied.

维持高液体摄入量的干预措施的有效性尚未得到充分研究。

We sought to determine whether a multicomponent behavioural intervention programme to promote high fluid intake reduces symptomatic stone recurrence, compared with a control.

我们试图确定，旨在促进高液体摄入量的多组分行为干预计划是否能减少症状性结石复发，与对照组相比。

Methods

In this randomised clinical trial, participants aged 12 years and older with a history of urinary stone disease and low 24 h urine volumes based on current guidelines were enrolled at six academic medical centres in the USA.

在这项随机临床试验中，根据当前指南，基于24小时尿量低的美国六个学术医疗中心招募了12岁及以上的有尿路结石病史的参与者。

Participants were randomly assigned in a 1:1 ratio to a multicomponent behavioural intervention designed to promote increased fluid intake or to the control group receiving guideline-concordant care.

参与者以1:1的比例随机分配到一个多组分的行为干预组，旨在促进增加液体摄入量，或分配到接受指南一致护理的对照组。

The intervention consisted of a fluid prescription, financial incentives to adhere to fluid prescription, health coaching to overcome barriers to consuming more fluids, and patient-selected approaches such as text messaging to maintain increased fluid intake.

干预措施包括液体处方、遵守液体处方的经济激励、克服增加液体摄入障碍的健康指导，以及患者选择的方法，如短信，以维持增加的液体摄入量。

Randomisation assignment was computer-generated remotely, and investigators, treating physicians, outcome assessors, and adjudicators were masked to group assignment.

随机分配是通过远程计算机生成的，研究者、治疗医生、结果评估者和裁决者对分组情况均不知情。

The primary outcome was symptomatic stone recurrence defined as stone passage or procedural intervention for stone(s) during a 2-year follow-up period, analysed in the intention-to-treatpopulation.

主要结果是症状性结石复发，定义为在2年的随访期间，结石通过或因结石进行程序干预，分析在意向治疗人群中进行。

Secondary outcomes included change in 24 h urine volume, urinary symptoms, radiographic stone recurrence or growth, and a composite outcome of symptomatic stone recurrence, new stone formation, and growth of existing stone(s); hyponatremia requiring hospitalisation was the safety endpoint.

次要结果包括24小时尿量的变化、尿路症状、放射学上的结石复发或生长，以及症状性结石复发、新结石形成和现有结石生长的综合结果；需要住院治疗的低钠血症是安全终点。

This trial is registered with ClinicalTrials.gov, NCT03244189.

该试验已在ClinicalTrials.gov注册，注册号为NCT03244189。

Results

Between Oct 26, 2017, and Feb 18, 2022, 1658 participants were randomly assigned to intervention (n=826) and control (n=832) groups (median age 44 years [IQR 29-59]; 946 [57%] female).

在2017年10月26日至2022年2月18日期间，共有1658名参与者被随机分配到干预组(n=826)和对照组(n=832)（中位年龄44岁[IQR 29-59]；946名[57%]为女性）。

At a median follow-up of 738 days (IQR 711-778), symptomatic stone events occurred in 154 (19%) participants in the intervention group and 165 (20%) in the control group (hazard ratio0·96, 95% CI 0·77-1·20).

在中位随访738天（IQR 711-778天）时，干预组中有154名（19%）参与者和对照组中有165名（20%）参与者发生了有症状的结石事件（风险比0·96，95%置信区间0·77-1·20）。

Among these 1658 participants, 1104 (66·6%) were recurrent stone formers. 24 h urine volume increased from baseline in both groups and was higher in the intervention group at months 6, 12, 18, and 24 compared with the control group.

在这1658名参与者中，有1104名（66.6%）是复发性结石形成者。两组的24小时尿量均从基线开始增加，并且在干预组的6个月、12个月、18个月和24个月时均高于对照组。

Urinary storage symptoms of frequency, urgency, and nocturia were greater in the intervention group versus control at months 6 and 12 but not at other timepoints.

在干预组和对照组中，尿储留症状如尿频、尿急和夜尿在6个月和12个月时比其他时间点更明显。

There was no difference in stone growth of at least 2 mm or new stones between groups from baseline to end-of-study imaging, and the composite outcome of symptomatic stone recurrence, new stone formation, or stone growth of at least 2 mm was also not statistically different between groups.

从基线到研究结束时的影像学检查中，两组之间至少有2毫米的结石生长或新结石形成没有差异，且有症状的结石复发、新结石形成或至少2毫米的结石生长的复合结果在两组之间也没有统计学差异。

No episodes of hyponatremia requiring hospitalisation (safety endpoint) were reported; 12 (1%) participants in the intervention group had asymptomatic hyponatraemia versus two (<1%) participants in the control group.

没有报告需要住院治疗的低钠血症发作（安全终点）；干预组有12名（1%）参与者出现无症状的低钠血症，而对照组有两名（<1%）参与者出现无症状的低钠血症。

interpretation

A behavioural intervention programme to promote fluid intake for secondary stone prevention did not reduce recurrent stone events but modestly increased urine volume compared with guideline-based care during a 2-year follow-up period.

一项旨在促进液体摄入以预防结石复发的行为干预计划，在为期两年的随访期间，并未减少结石复发事件，但与基于指南的护理相比，适度增加了尿量。

funding

National Institute of Diabetes and Digestive and Kidney Diseases.

国家糖尿病、消化和肾脏疾病研究所。