Prevention of Urinary Stones With Hydration

Completed · Not applicable

Conditions studied: Urinary Stones

In brief

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.

Key facts

Study ID

NCT03244189

Run by

Duke University

People needed

1658

Starts

2017-10-04

Expected to finish

2024-05-31

Last updated by the study team

2026-06-25

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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
• Women who are currently pregnant or planning pregnancy within 2 years.
• Renal transplant recipient
• Bedridden study participants (ECOG ≥ 3)
• Uncorrected anatomical obstruction of the urinary tract
• History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture)
• Exclusions due to medication use:
• Chronic use of lithium
• Long-term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)
• Intake of narcotic medication on a daily basis for >30 days prior to enrollment
• Supplemental Vitamin C (> 1 g daily)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Washington University, St. Louis — St Louis, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital — Dallas, Texas, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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