CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,658 enrolled / 1,658 target
Drug / intervention
Fluid prescription +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03244189
NCT03244189N/ACompletedHigh Momentum (15.8/mo)Completion was 25mo ago
CompareCT.gov

Prevention of Urinary Stones With Hydration

Duke University·interventional·Posted Aug 9, 2017·Updated Jun 25, 2026

In Brief

A clinical study evaluating Fluid prescription, Financial incentive, and 1 other intervention for Urinary Stones. Completed, enrolled 1,658 participants across 8 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Stones
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 9, 2017
Enrollment StartOct 4, 2017
Primary CompletionMay 18, 2024
Study CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 8.9 years ago

Arms & Interventions

Interventionexperimental

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 prescriptionBehavioral: Financial incentiveBehavioral: Structured Problem Solving
Controlno_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 prescriptionbehavioral

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 incentivebehavioral

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 Solvingbehavioral

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