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Comparison · NCT03244189-6edaa076

Intervention vs Control: Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Intervention vs Control: Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension. Trial comparisons, record NCT03244189-6edaa076. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03244189-6edaa076

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.05450.0410.0721wilson
Risk in group 20.03850.02740.0538wilson
Risk difference, group 1 minus group 20.016-0.004420.0369newcombe hybrid score
Risk ratio, group 1 over group 21.420.912.21log
Odds ratio, group 1 over group 21.440.9062.29log
Number needed to treat, for one more participant with the outcome on Intervention than on Control62.4from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Intervention
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.~Fluid prescription: 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.~Financial incentive: Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.~Structured Problem Solving: Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.
45826OG000
Group 2Control
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.
32832OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension
Description
Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan and ultrasound).
Time frame
Baseline through approximately 24 months
Population

Source ClinicalTrials.gov

Trial

Title
Prevention of Urinary Stones With Hydration
NCT number
NCT03244189
Phases
NA
Conditions
Urinary Stones
Interventions
Fluid prescription, Financial incentive, Structured Problem Solving
Lead sponsor
Duke University
Results first posted
2025-08-05

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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