Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.
Date
2021-06
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
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.Type
Department
Description
Provenance
Citation
Permalink
Published Version (Please cite this version)
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.
Collections
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.