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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03244189
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : July 22, 2019
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 9, 2017
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE September 13, 2017
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03244189 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • 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.
  • Change in size 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Prevention of Urinary Stones With Hydration
Official Title  ICMJE Prevention of Urinary Stones With Hydration
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.
Primary Purpose: Prevention
Condition  ICMJE Urinary Stones
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention
    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
    • Behavioral: Financial incentive
    • Behavioral: Structured Problem Solving
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged ≥ 12 years
  2. At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following:

    1. Stone passage
    2. Procedural intervention
    3. Radiographically or ultrasonographically confirmed stone with any of the following:

    i. Gross hematuria

    ii. Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider

    iii. A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider

  3. Low 24‐hr urine volume

    1. ≥18 years old: <1.8 L/day
    2. <18 years old: <20 ml/Kg/day up to 1.8L/day
  4. Able to provide informed consent (parental permission for children)
  5. Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study‐provided wireless enabled "smart" bottle

Exclusion Criteria:

  1. Spinal cord injury
  2. Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy <1 year before screening.
  3. Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease

    1. Cystinuria
    2. Primary hyperoxaluria
    3. Primary xanthinuria
    4. Primary hyperparathyroidism
    5. Sarcoidosis
    6. Medullary sponge kidney
  4. History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo‐osmolality (serum osmolality <275 mosm/kg)
  5. Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses

    1. History of or current Crohn's disease, ulcerative colitis, short gut syndrome (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection), chronic diarrhea, or GI tract ostomy.
    2. History of malabsorptive (e.g., Roux‐en‐Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures
    3. Congestive heart failure

    i. NYHA class II or greater, and/or ii. Hospital admission in the past year for heart failure d. Lung disease with a home oxygen requirement e. Chronic kidney disease (eGFR <30 ml/min/1.7 m2 over a 3‐month period) i. For adults (age ≥18), we will use the CKD‐Epi equation which requires the measurement of serum creatinine only. ii. For children (age <18), we will use the bedside Schwartz (CKiD) formula. f. Nephrotic syndrome (>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites

  6. Women who are currently pregnant or planning pregnancy within 2 years.
  7. Renal transplant recipient
  8. Bedridden study participants (ECOG ≥ 3)
  9. Uncorrected anatomical obstruction of the urinary tract
  10. History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture)
  11. Exclusions due to medication use:

    1. Chronic use of lithium
    2. Long‐term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)
    3. Intake of narcotic medication on a daily basis for >30 days prior to enrollment
    4. Supplemental Vitamin C (> 1 g daily)
  12. Individuals with stones that have developed after the initiation of medications that are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide), high dose vitamin C (> 1 g daily), high dose calcium supplementation (> 1,200 mg daily) AND who have discontinued or plan to discontinue these medications.
  13. Individuals with stones composed of medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir) AND who have discontinued or plan to discontinue these medications.

    Note: Individuals who are on long‐term medications that increase the risk of stone disease, who cannot stop these medications due to other chronic conditions (e.g., HIV) and who may reduce their risk for stone recurrence through increased fluid intake, will be eligible to participate in the trial. Examples of these medications include:

    1. Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)
    2. Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
  14. Study participants <2 yrs life expectancy
  15. Non‐English Speakers
  16. History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
  17. Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.
  18. Psychiatric conditions impairing compliance with the study
  19. Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol)
  20. Individual who will be unable to participate in the protocol in the judgment of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Johnson 919-323-6831
Contact: Sharon Settles
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03244189
Other Study ID Numbers  ICMJE Pro00083271
1U01DK110988 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data and samples, for subjects who consent to sharing, will be sent to the NIDDK Data and Biological Samples Repository following database lock.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 2 years after the last visit of the last participant randomized.
Access Criteria: Anyone with access to the NIDDK Data and Biological Samples Repository
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Charles Scales, MD, MSHS Duke University
PRS Account Duke University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP