Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial
Charles D Scales Jr, Alana C Desai, Jonathan D Harper, H Henry Lai, Naim M Maalouf, Peter P Reese, Gregory E Tasian, Hussein R Al-Khalidi, Ziya Kirkali, Hunter Wessells, Urinary Stone Disease Research Network, Sandra Amaral, Janet Audrain-McGovern, Brittney Henderson, Kristen Koepsell, Adam Mussell, Jodi A Antonelli, Linda A Baker, Joyce Obiaro, Cynthia Rangel, Martinez Hill, Madeline Worsham, Fionnuala Cormack, Mathew Sorensen, Karyn Yonekawa, Holly Covert, Tristan Baxter, Elsa Ayala, Vincent Mellnick, Douglas Coplen, Juanita Taylor, Aleksandra Klim, Deborah Ksiazek, Sri Sivalingam, Katherine Dell, Juan Calle, Paige Gotwald, Marina Markovic, John Lieske, Andrew Rule, Stephen Erickson, Aaron Potrezke, Andrea Ferrero, David Sas, Angela Waits, Courtney Lenort, Kevin Weinfurt, Hayden Bosworth, Honqiu Yang, Laura Johnson, Angela Venetta, Omar Thompson, Charles D Scales Jr, Alana C Desai, Jonathan D Harper, H Henry Lai, Naim M Maalouf, Peter P Reese, Gregory E Tasian, Hussein R Al-Khalidi, Ziya Kirkali, Hunter Wessells, Urinary Stone Disease Research Network, Sandra Amaral, Janet Audrain-McGovern, Brittney Henderson, Kristen Koepsell, Adam Mussell, Jodi A Antonelli, Linda A Baker, Joyce Obiaro, Cynthia Rangel, Martinez Hill, Madeline Worsham, Fionnuala Cormack, Mathew Sorensen, Karyn Yonekawa, Holly Covert, Tristan Baxter, Elsa Ayala, Vincent Mellnick, Douglas Coplen, Juanita Taylor, Aleksandra Klim, Deborah Ksiazek, Sri Sivalingam, Katherine Dell, Juan Calle, Paige Gotwald, Marina Markovic, John Lieske, Andrew Rule, Stephen Erickson, Aaron Potrezke, Andrea Ferrero, David Sas, Angela Waits, Courtney Lenort, Kevin Weinfurt, Hayden Bosworth, Honqiu Yang, Laura Johnson, Angela Venetta, Omar Thompson
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.
Keywords: RCT design; Urinary stone disease (USD); behavioral intervention; financial incentive; fluid prescription; health coaching; increased fluid intake; kidney disease prevention; kidney stone; lifestyle change; lower urinary tract symptoms; modifiable risk factor; randomized clinical trial (RCT); stone recurrence; urine volume.
Copyright © 2020 National Kidney Foundation, Inc. All rights reserved.
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Source: PubMed