Prevention of Urinary Stones With Hydration (PUSH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03244189|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2017
Last Update Posted : November 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Urinary Stones||Behavioral: Fluid prescription Behavioral: Financial incentive Behavioral: Structured Problem Solving||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||1658 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.|
|Official Title:||Prevention of Urinary Stones With Hydration|
|Actual Study Start Date :||October 4, 2017|
|Estimated Primary Completion Date :||May 13, 2024|
|Estimated Study Completion Date :||May 13, 2024|
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.
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.
No Intervention: Control
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.
- Stone passage observed and/or captured by the study participant. [ Time Frame: From Baseline through 24 months. ]Will be measured by the time from Baseline to the passage of 1 or more stones by a participant.
- Procedural intervention for symptomatic stone [ Time Frame: From Baseline through 24 months. ]From Baseline through 24 months; will be measured by the time from Baseline to a procedure to remove a symptomatic stone by a participant.
- Any procedural intervention for removal of asymptomatic renal or ureteral stone [ Time Frame: From Baseline through 24 months. ]Will be measured by the time from Baseline to a procedure to remove an asymptomatic stone by a participant.
- Asymptomatic formation of new stone detected by imaging [ Time Frame: From Baseline through 24 months. ]Will be measured by the time from Baseline to the formation of an asymptomatic stone by a participant.
- Growth of existing stone by ≥ 2 mm in any dimension detected by imaging [ Time Frame: From Baseline through 24 months. ]Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan or ultrasound).
- Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by ≥2 mm in any dimension detected by imaging [ Time Frame: From Baseline through 24 months. ]
- 24 hour urine total volume [ Time Frame: From Baseline through 24 months. ]Will measure and compare 24 hour urine volumes from screening through 24 months.
- Costs of study interventions and treatments for USD during the follow-up period [ Time Frame: Compared total between Baseline and the Month 24 visit. ]
- Presence of lower urinary tract symptoms (Comprehensive Assessment of Self-reported Urinary Symptoms) [ Time Frame: From Baseline through the Month 24 visit. ]Will compare the results of the CASUS questionnaires completed throughout the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244189
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University, St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19146|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Charles Scales, MD, MSHS||Duke University|