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

Publication ,  Journal Article
Scales, CD; Desai, AC; Harper, JD; Lai, HH; Maalouf, NM; Reese, PP; Tasian, GE; Al-Khalidi, HR; Kirkali, Z; Wessells, H ...
Published in: Am J Kidney Dis
June 2021

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.

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Published In

Am J Kidney Dis

DOI

EISSN

1523-6838

Publication Date

June 2021

Volume

77

Issue

6

Start / End Page

898 / 906.e1

Location

United States

Related Subject Headings

  • Urology & Nephrology
  • Urinary Calculi
  • Randomized Controlled Trials as Topic
  • Humans
  • Drinking
  • Adult
  • Adolescent
  • 3202 Clinical sciences
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences
 

Citation

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Scales, C. D., Desai, A. C., Harper, J. D., Lai, H. H., Maalouf, N. M., Reese, P. P., … Urinary Stone Disease Research Network, . (2021). Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial. Am J Kidney Dis, 77(6), 898-906.e1. https://doi.org/10.1053/j.ajkd.2020.09.016
Scales, Charles D., Alana C. Desai, Jonathan D. Harper, H Henry Lai, Naim M. Maalouf, Peter P. Reese, Gregory E. Tasian, et al. “Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.Am J Kidney Dis 77, no. 6 (June 2021): 898-906.e1. https://doi.org/10.1053/j.ajkd.2020.09.016.
Scales CD, Desai AC, Harper JD, Lai HH, Maalouf NM, Reese PP, et al. Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial. Am J Kidney Dis. 2021 Jun;77(6):898-906.e1.
Scales, Charles D., et al. “Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.Am J Kidney Dis, vol. 77, no. 6, June 2021, pp. 898-906.e1. Pubmed, doi:10.1053/j.ajkd.2020.09.016.
Scales CD, Desai AC, Harper JD, Lai HH, Maalouf NM, Reese PP, Tasian GE, Al-Khalidi HR, Kirkali Z, Wessells H, Urinary Stone Disease Research Network. Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial. Am J Kidney Dis. 2021 Jun;77(6):898-906.e1.
Journal cover image

Published In

Am J Kidney Dis

DOI

EISSN

1523-6838

Publication Date

June 2021

Volume

77

Issue

6

Start / End Page

898 / 906.e1

Location

United States

Related Subject Headings

  • Urology & Nephrology
  • Urinary Calculi
  • Randomized Controlled Trials as Topic
  • Humans
  • Drinking
  • Adult
  • Adolescent
  • 3202 Clinical sciences
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences