Hydration Strategy for Preventing Kidney Stones
(PUSH Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byCharles Scales, MD, MSHS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults and children over 12 who've had a kidney stone in the past 3-5 years, with low daily urine volume, can join this trial. They must be able to consent (parents for minors), use a smart device with a special bottle provided by the study, and not plan on pregnancy within two years. Exclusions include spinal cord injury, active cancer treatment (except skin cancer), certain genetic or infectious stone diseases, severe medical conditions limiting fluid intake, chronic medication use affecting stones, non-English speakers, psychiatric issues affecting compliance.

Inclusion Criteria

I am 12 years old or older.

I have had a painful kidney stone event or needed treatment for one in the last 3-5 years.

Able to provide informed consent (parental permission for children)

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Exclusion Criteria

I have a specific condition like cystinuria or sarcoidosis that affects my kidney stones.

Non-English Speakers

Psychiatric conditions impairing compliance with the study

See 15 more

Treatment Details

Interventions

Financial incentive (Behavioural Intervention)
Fluid prescription (Behavioural Intervention)
Structured Problem Solving (Behavioural Intervention)

Trial OverviewThe trial tests if drinking more water helps prevent new kidney stones from forming. Participants will receive behavioral interventions like fluid prescriptions and financial incentives to increase their water intake over two years. The goal is to see if these strategies reduce the risk of further kidney stones.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment3 Interventions

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.

Group II: ControlActive Control1 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.