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N/A N=1,658 Randomized Single-blind Prevention

Prevention of Urinary Stones With Hydration

Urinary Stones

Enrolled (actual)
1,658
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants With a Symptomatic Stone Event — 154; 165 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fluid prescription (Behavioral); Financial incentive (Behavioral); Structured Problem Solving (Behavioral)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Duke University
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With a Symptomatic Stone Event
154; 165
SECONDARY
Number of Participants With Asymptomatic Formation of New Stone
82; 83
SECONDARY
Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension
45; 32
SECONDARY
Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension
232; 236
SECONDARY
24-hour Urine Total Volume
1.81; 1.58; 1.70; 1.57; 1.70; 1.55
SECONDARY
Costs of Study Interventions and Treatments for USD During the Follow-up Period
SECONDARY
Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)
6.11; 5.94; 6.23; 6.11; 6.26; 6.05

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.

Eligibility Criteria

Inclusion Criteria

  • 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: 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)
  • Individuals with stones that have developed after the initiation of medications that are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide), high dose vitamin C (> 1 g daily), high dose calcium supplementation (> 1,200 mg daily) AND who have discontinued or plan to discontinue these medications.
  • Individuals with stones composed of medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir) AND who have discontinued or plan to discontinue these medications.

Note: Individuals who are on long-term medications that increase the risk of stone disease, who cannot stop these medications due to other chronic conditions (e.g., HIV) and who may reduce their risk for stone recurrence through increased fluid intake, will be eligible to participate in the trial. Examples of these medications include:

  • Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)
  • Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
  • Study participants <2 yrs life expectancy
  • Non-English Speakers
  • History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
  • Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.
  • Psychiatric conditions impairing compliance with the study
  • Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol)
  • Individual who will be unable to participate in the protocol in the judgment of the investigator.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03244189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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