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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • 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,

Published Date

  • June 2021

Published In

Volume / Issue

  • 77 / 6

Start / End Page

  • 898 - 906.e1

PubMed ID

  • 33212205

Pubmed Central ID

  • PMC8124076

Electronic International Standard Serial Number (EISSN)

  • 1523-6838

Digital Object Identifier (DOI)

  • 10.1053/j.ajkd.2020.09.016

Language

  • eng

Conference Location

  • United States