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Hydration Strategy for Preventing Kidney Stones (PUSH Trial)
N/A
Waitlist Available
Led By Charles Scales, MD, MSHS
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥ 12 years
Low 24-hr urine volume: ≥18 years old: <2.0 L/day, <18 years old: <25 ml/Kg/day up to 2.0L/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through 24 months.
Awards & highlights
PUSH Trial Summary
This trial will investigate whether increasing fluid intake and output can reduce the risk of urinary stone disease progression.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
There are no direct side effects from the interventions as they involve increasing water consumption and using behavioral techniques to encourage hydration. However, participants should monitor for any discomfort due to increased fluid intake.
PUSH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Select...
I am an adult and my daily urine output is less than 2 liters, or I am under 18 and my daily urine output is less than 25 ml/kg up to 2 liters.
PUSH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through 24 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Any procedural intervention for removal of asymptomatic renal or ureteral stone
Procedural intervention for symptomatic stone
Stone passage observed and/or captured by the study participant.
Secondary outcome measures
24 hour urine total volume
Asymptomatic formation of new stone detected by imaging
Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by ≥2 mm in any dimension detected by imaging
+3 morePUSH Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Financial incentive
2016
Completed Phase 3
~61520
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,418,411 Total Patients Enrolled
2 Trials studying Kidney Stones
390 Patients Enrolled for Kidney Stones
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,313,408 Total Patients Enrolled
6 Trials studying Kidney Stones
590 Patients Enrolled for Kidney Stones
Charles Scales, MD, MSHSPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific condition like cystinuria or sarcoidosis that affects my kidney stones.I am not a prisoner and do not have cognitive impairments affecting my study participation.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.I have a spinal cord injury.I have a condition that prevents me from drinking a lot of fluids.I am bedridden and cannot care for myself.I have a blockage in my urinary system that hasn't been fixed.I don't use lithium, steroids, daily narcotics, high-dose Vitamin C, or have stones from medication.My doctor expects I have less than 2 years to live.I have a history of SIADH.I have a unique urinary system structure, like a single kidney or enlarged ureter.I am not currently receiving cancer treatment, except for basal cell skin cancer, or I finished my initial cancer therapy more than a year ago.I am not pregnant and do not plan to become pregnant in the next 2 years.You have a history of very low sodium levels in your blood or low osmolality.I have had more than 3 urinary tract infections in a year, confirmed by tests.I am an adult and my daily urine output is less than 2 liters, or I am under 18 and my daily urine output is less than 25 ml/kg up to 2 liters.I have received a kidney transplant.The investigator believes I can't follow the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations are participating in the trial's execution?
"8 medical centres are participating in this experimental trial, such as Children's Hospital in Dallas, Cleveland Clinic in Cleveland and University of Pennsylvania at Philadelphia. Additionally, there are 8 other sites that have been included."
Answered by AI
Is this research endeavor currently looking to enroll participants?
"The data posted on clinicaltrials.gov affirms that this medical trial is no longer recruiting participants, as the last update to it was made on November 10th 2022. Nonetheless, there are still 63 other trials currently looking for patients to join them in their research efforts."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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