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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,658
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.
Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.
Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.
Mayo Clinic
Rochester, Minnesota, United States
Washington University, St. Louis
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Number of Participants With a Symptomatic Stone Event
Having a symptomatic stone event was defined as meeting any 1 of 2 criteria - stone passage or a procedural intervention for a stone (whether the stone was causing symptoms or not).
Time frame: Baseline through approximately 24 months
Number of Participants With Asymptomatic Formation of New Stone
Time frame: Up to approximately 24 months
Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension
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
Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension
Time frame: Baseline through approximately 24 months
24-hour Urine Total Volume
Time frame: 6, 12, 18, and 24 months
Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)
The CASUS is a tool used to assess lower urinary tract symptoms (LUTS) in individuals, providing a comprehensive evaluation of various urinary issues. It's designed to capture a wide range of symptoms, including storage, voiding, post-micturition, urgency, incontinence, and abnormal bladder sensations. The total score ranges from 0 to 38, where a higher score indicates greater urinary symptoms.
Time frame: Baseline, 6, 12, 18, and 24 months
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States