Prevention of Urinary Stones With Hydration — PUSH  

Urinary Stones Clinical Trial

Official title: Prevention of Urinary Stones With Hydration

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urinary Stones
• Urolithiasis

• NCT number: NCT03244189
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: October 4, 2017
• Completion date: May 31, 2024