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Prevention of Urinary Stones With Hydration

NCT03244189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1658

Last updated 2025-08-05

Study results available
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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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Charles Scales, MD, MSHS · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2024-05-18
Completion
2024-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244189 on ClinicalTrials.gov