NCT03244189

Prevention of Urinary Stones With Hydration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,658 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a two arm randomized controlled trial that incorporates pragmatic features, an adaptable intervention, patient choice, and remote monitoring of fluid intake through a "smart" water bottle. The study period is 24 months and will enroll approximately 1642 participants. Randomization will be stratified within a study site by age (adult vs. adolescent) and first time vs. recurrent stone former. Intervention and control arm study participants will receive a smart water bottle that records daily fluid consumption, usual care including guideline-based recommendations of adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.

Conditions

• Urinary Stones

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-04
• Primary completion: 2024-05-18
• Completion: 2024-05-31
• First posted: 2017-08-09
• Last updated: 2025-08-05
• Results posted: 2025-08-05

Locations

8 sites across 1 country: United States