Journal article
Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial
American journal of kidney diseases, Vol.77(6), pp.898-906.e1
06/01/2021
DOI: 10.1053/j.ajkd.2020.09.016
PMID: 33212205
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.
Details
- Title: Subtitle
- Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial
- Creators
- Charles D. Scales - Duke University Health SystemAlana C. Desai - Washington University in St. LouisJonathan D. Harper - University of WashingtonH. Henry Lai - Washington University in St. LouisNaim M. Maalouf - The University of Texas Southwestern Medical CenterPeter P. Reese - University of PennsylvaniaGregory E. Tasian - Children's Hospital of PhiladelphiaHussein R. Al-Khalidi - Duke UniversityZiya Kirkali - NIDDKD, Bethesda, MD USAHunter Wessel - University of WashingtonUrinary Stone Dis Res Network
- Resource Type
- Journal article
- Publication Details
- American journal of kidney diseases, Vol.77(6), pp.898-906.e1
- DOI
- 10.1053/j.ajkd.2020.09.016
- PMID
- 33212205
- NLM abbreviation
- Am J Kidney Dis
- ISSN
- 0272-6386
- eISSN
- 1523-6838
- Publisher
- Elsevier
- Number of pages
- 10
- Grant note
- DK110961 / Children's Hospital of Philadelphia DK110995 / University of Texas Southwestern Medical Center DK110988 / Drs Scales and Al-Khalidi; Duke University DK110954 / University of Washington DK110986 / NIDDK; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
- Language
- English
- Date published
- 06/01/2021
- Academic Unit
- Urology
- Record Identifier
- 9985244562302771
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