Prevention of Urinary Stones With Hydration

NCT03244189 | Completed Results DMC

• 2 other identifiers: Pro000832711U01DK110988
• Study Type: interventional
• Target: 1,658
• Locations: 1 country
• Sites: 8

Brief Summary

A randomized clinical trial to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. The primary aim of the trial is to determine whether a multi-component program of behavioral interventions to increase fluid intake will result in reduced risk of stone disease progression over a 2-year period.

Conditions

Urinary Stones

Keywords

Urinary Stone Disease; Kidney Stone; Urinary Calculi

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Symptomatic Stone Event

  Having a symptomatic stone event was defined as meeting any 1 of 2 criteria - stone passage or a procedural intervention for a stone (whether the stone was causing symptoms or not).

  Baseline through approximately 24 months

Secondary Outcomes (6)

• Number of Participants With Asymptomatic Formation of New Stone

  Up to approximately 24 months

• Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension

  Baseline through approximately 24 months

• Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension

  Baseline through approximately 24 months

• 24-hour Urine Total Volume

  6, 12, 18, and 24 months

• Costs of Study Interventions and Treatments for USD During the Follow-up Period

  Baseline through approximately 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.

Behavioral: Fluid prescription; Behavioral: Financial incentive; Behavioral: Structured Problem Solving

Control

NO INTERVENTION

Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a "smart" water bottle with capability to self-monitor their fluid intake.

Interventions

Fluid prescription BEHAVIORAL

The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.

Intervention

Financial incentive BEHAVIORAL

Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.

Intervention

Structured Problem Solving BEHAVIORAL

Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.

Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 12 years
• At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following:
• Stone passage
• Procedural intervention
• Radiographically or ultrasonographically confirmed stone with any of the following:
• i. Gross hematuria ii. Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider iii. A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider
• Low 24-hr urine volume
• ≥18 years old: \<2.0 L/day
• \<18 years old: \<25 ml/Kg/day up to 2.0L/day
• Able to provide informed consent (parental permission for children)
• Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study-provided wireless enabled "smart" bottle

You may not qualify if:

• Spinal cord injury
• Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy \<1 year before screening.
• Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease
• Cystinuria
• Primary hyperoxaluria
• Primary xanthinuria
• Primary hyperparathyroidism
• Sarcoidosis
• Medullary sponge kidney
• History or presence of hyponatremia (serum sodium \<130 mmol/L) or hypo-osmolality (serum osmolality \<275 mosm/kg)
• Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses
• History of or current Crohn's disease, ulcerative colitis, short gut syndrome (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection), chronic diarrhea, or GI tract ostomy.
• History of malabsorptive (e.g., Roux-en-Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures
• Congestive heart failure
• i. NYHA class II or greater, and/or ii. Hospital admission in the past year for heart failure d. Lung disease with a home oxygen requirement e. Chronic kidney disease (eGFR \<30 ml/min/1.7 m2 over a 3-month period) i. For adults (age ≥18), we will use the CKD-Epi equation which requires the measurement of serum creatinine only. ii. For children (age \<18), we will use the bedside Schwartz (CKiD) formula. f. Nephrotic syndrome (\>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (8)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Children's Hospital

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• Wessells H, Lieske JC, Lai HH, Al-Khalidi HR, Desai AC, Harper JD, Kirkali Z, Maalouf NM, McCune R, Reese PP, Scales CD, Tasian GE; NIDDK Urinary Stone Disease Research Network. Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial. Urology. 2024 Dec;194:27-35. doi: 10.1016/j.urology.2024.08.026. Epub 2024 Sep 4.

  PMID: 39242045 DERIVED

• Reese PP, Shah S, Funsten E, Amaral S, Audrain-McGovern J, Koepsell K, Wessells H, Harper JD, McCune R, Scales CD Jr, Kirkali Z, Maalouf NM, Lai HH, Desai AC, Al-Khalidi HR, Tasian GE. Using structured problem solving to promote fluid consumption in the prevention of urinary stones with hydration (PUSH) trial. BMC Nephrol. 2024 May 28;25(1):183. doi: 10.1186/s12882-024-03605-y.

  PMID: 38807063 DERIVED

• Scales CD Jr, 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. doi: 10.1053/j.ajkd.2020.09.016. Epub 2020 Nov 16.

  PMID: 33212205 DERIVED

Related Links

• The Urinary Stone Disease Research Network (USDRN) website. The USDRN is the program conducting the PUSH study.

MeSH Terms

Conditions

Urinary Calculi; Kidney Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases

Results Point of Contact

• Title: Charles D. Scales Jr, MD MSHS FACS
• Organization: Duke University

chuck.scales@duke.edu

919-684-1999

Study Officials

• Charles Scales, MD, MSHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 9, 2017
• Study Start: October 4, 2017
• Primary Completion: May 18, 2024
• Study Completion: May 31, 2024
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years after the last visit of the last participant randomized.
• Access Criteria: Anyone with access to the NIDDK Data and Biological Samples Repository

Locations

US (8)