Charles D Scales1, Alana C Desai2, Jonathan D Harper3, H Henry Lai2, Naim M Maalouf4, Peter P Reese5, Gregory E Tasian6, Hussein R Al-Khalidi7, Ziya Kirkali8, Hunter Wessells3. 1. Urologic Surgery and Population Health Science, Duke Surgical Center for Outcomes Research, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: chuck.scales@duke.edu. 2. Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St Louis, MO. 3. Department of Urology, University of Washington School of Medicine, Seattle, WA. 4. Department of Internal Medicine and Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX. 5. Renal-Electrolyte and Hypertension Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. 6. Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Division of Pediatric Urology, Department of Surgery, The Children's Hospital of Philadelphia, Philadelphia, PA. 7. Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. 8. National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
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.
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.
Authors: Margaret S Pearle; David S Goldfarb; Dean G Assimos; Gary Curhan; Cynthia J Denu-Ciocca; Brian R Matlaga; Manoj Monga; Kristina L Penniston; Glenn M Preminger; Thomas M T Turk; James R White Journal: J Urol Date: 2014-05-20 Impact factor: 7.450
Authors: K Silverman; C J Wong; S T Higgins; R K Brooner; I D Montoya; C Contoreggi; A Umbricht-Schneiter; C R Schuster; K L Preston Journal: Drug Alcohol Depend Date: 1996-06 Impact factor: 4.492
Authors: Wonngarm Kittanamongkolchai; Lisa E Vaughan; Felicity T Enders; Tsering Dhondup; Ramila A Mehta; Amy E Krambeck; Cynthia H McCollough; Terri J Vrtiska; John C Lieske; Andrew D Rule Journal: Mayo Clin Proc Date: 2018-02-14 Impact factor: 7.616
Authors: Sarah Tarplin; Manoj Monga; Karen L Stern; Lipika R McCauley; Carl Sarkissian; Mike M Nguyen Journal: Urology Date: 2015-11-04 Impact factor: 2.649
Authors: Kevin G Volpp; George Loewenstein; Andrea B Troxel; Jalpa Doshi; Maureen Price; Mitchell Laskin; Stephen E Kimmel Journal: BMC Health Serv Res Date: 2008-12-23 Impact factor: 2.655
Authors: Nilofar Dorani; Miranda M Zhang; Gopala K Rangan; Lara Abu-Zarour; Ho Ching Lau; Alexandra Munt; Ashley N Chandra; Sayanthooran Saravanabavan; Anna Rangan; Jennifer Q J Zhang; Martin Howell; Annette Ty Wong Journal: BMJ Open Date: 2021-12-09 Impact factor: 2.692
Authors: Jonathan S Ellison; Matthew Lorenzo; Hunter Beck; Ruth Beck; David I Chu; Christopher Forrest; Jing Huang; Amy Kratchman; Anna Kurth; Laura Kurth; Michael Kurtz; Thomas Lendvay; Renae Sturm; Gregory Tasian Journal: BMJ Open Date: 2022-04-05 Impact factor: 2.692
Authors: Charles D Scales; H Henry Lai; Alana C Desai; Jodi A Antonelli; Naim M Maalouf; Gregory E Tasian; Peter P Reese; Michele Curatolo; Kevin Weinfurt; Hussein R Al-Khalidi; Hunter Wessells; Ziya Kirkali; Jonathan D Harper Journal: J Endourol Date: 2020-11-16 Impact factor: 2.619