Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.

Abstract

Rationale & objective

Although maintaining high fluid intake is an effective low-risk intervention for the secondary prevention of urinary stone disease, many patients with stones do not increase their fluid intake.

Study design

We describe the rationale and design of the Prevention of Urinary Stones With Hydration (PUSH) Study, a randomized trial of a multicomponent behavioral intervention program to increase and maintain high fluid intake. Participants are randomly assigned (1:1 ratio) to the intervention or control arm. The target sample size is 1,642 participants.

Setting & participants

Adults and adolescents 12 years and older with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of urinary stone disease and comorbid conditions precluding increased fluid intake.

Interventions

All participants receive usual care and a smart water bottle with smartphone application. Participants in the intervention arm receive a fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions. Control arm participants receive guideline-based fluid instructions.

Outcomes

The primary end point is recurrence of a symptomatic stone during 24 months of follow-up. Secondary end points include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.

Limitations

Periodic 24-hour urine volumes may not fully reflect daily behavior.

Conclusions

With its highly novel features, the PUSH Study will address an important health care problem.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases.

Trial registration

Registered at ClinicalTrials.gov with study number NCT03244189.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1053/j.ajkd.2020.09.016

Publication Info

Scales, Charles D, Alana C Desai, Jonathan D Harper, H Henry Lai, Naim M Maalouf, Peter P Reese, Gregory E Tasian, Hussein R Al-Khalidi, et al. (2021). Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial. American journal of kidney diseases : the official journal of the National Kidney Foundation, 77(6). pp. 898–906.e1. 10.1053/j.ajkd.2020.09.016 Retrieved from https://hdl.handle.net/10161/29639.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Scales

Charles Douglas Scales

Associate Professor of Urology

Charles D. Scales, Jr., MD MSHS FACS is Associate Dean for Clinical Research Initiatives and Associate Professor of Urology and Population Health Science. He completed medical school and residency training in urology at Duke University.  After residency, Dr. Scales completed the Robert Wood Johnson Foundation Clinical Scholars Program at UCLA, where he received advanced training in health services research, health policy, and quality of care.  He teaches these skills to future generations through the Duke Master of Management in Clinical Informatics (MMCi) degree program, and in 2025 will present his course, “Data, Information, and Health Care Transformation” for the 10th consecutive year.

 

From the research perspective, Dr. Scales has a longstanding interest in the epidemiology of and patient care for urinary stone disease.  Recent studies have redefined the epidemiology of urinary stone disease in the United States, compared the effectiveness of dominant stone removal technologies, and identified new opportunities for improving patient-centered and policy-relevant outcomes, such as unplanned care after procedural interventions.  His research and perspective on urinary stone disease has been highlighted in U.S. News & World Report, Reuters, NPR, and the Wall Street Journal, among other media outlets.

 

Currently, Dr. Scales leads a diverse health services and clinical research program at the Duke Clinical Research Institute, where he is the Principal Investigator for the Scientific Data and Research Center for the NIDDK Urinary Stone Disease Research Network (U01).  Within the USDRN, he leads the multicenter Prevention of Urinary Stones with Hydration (PUSH) randomized clinical trial, which is the largest randomized controlled stone prevention trial to date, and the multicenter Study to Enhance Understanding of Stent-Associated Symptoms (STENTS) cohort study. 

Al-Khalidi

Hussein Rashid Al-Khalidi

Professor of Biostatistics & Bioinformatics

My research interest includes design and analysis of cardiovascular clinical trials, medical devices, survival analysis, group-sequential analysis, time-to-recurrent or multiple events, continuous-time Markov models, stochastic process, linear model, dose-response modeling, design of experiments and adaptive designs.


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