A Study to Evaluate Effectiveness of Preventing Urinary Stones With Hydration

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 19-000054
    NCT ID: NCT03244189
    Sponsor Protocol Number: Pro00083271

About this study

The purpose of this trial is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Aged ≥ 12 years.
  • 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:
    • Stone passage;
    • Procedural intervention;
    • Radiographically or ultrasonographically confirmed stone with any of the following:
      • Gross hematuria;
      • Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider;
      • A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider.
  • 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.
  • Able to provide informed consent (parental permission for children).
  • Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study‐provided wireless enabled "smart" bottle.

Exclusion Criteria:

  • Spinal cord injury.
  • 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. 
  • Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease:
    • Cystinuria;
    • Primary hyperoxaluria;
    • Primary xanthinuria;
    • Primary hyperparathyroidism;
    • Sarcoidosis;
    • Medullary sponge kidney.
  • History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo‐osmolality (serum osmolality <275 mosm/kg).
  • Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses:
    • 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.
    • History of malabsorptive (e.g., Roux‐en‐Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures.
    • Congestive heart failure:
      • NYHA class II or greater; and/or
      • Hospital admission in the past year for heart failure.
    • Lung disease with a home oxygen requirement.
    • Chronic kidney disease (eGFR <30 ml/min/1.7 m2 over a 3‐month period):
      • For adults (age ≥18), we will use the CKD‐Epi equation which requires the measurement of serum creatinine only;
      • For children (age <18), we will use the bedside Schwartz (CKiD) formula.
    • Nephrotic syndrome (>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites.
  • Women who are currently pregnant or planning pregnancy within 2 years.
  • Renal transplant recipient.
  • Bedridden study participants (ECOG ≥ 3).
  • Uncorrected anatomical obstruction of the urinary tract.
  • History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture).
  • Exclusions due to medication use:
    • Chronic use of lithium'
    • Long‐term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)'
    • Intake of narcotic medication on a daily basis for >30 days prior to enrollment'
    • Supplemental Vitamin C (> 1 g daily).
  • 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.
  • 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:
      • Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide);
      • Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
  • Study participants <2 yrs life expectancy.
  • Non‐English Speakers.
  • History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).
  • Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.
  • Psychiatric conditions impairing compliance with the study.
  • Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol).
  • Individual who will be unable to participate in the protocol in the judgment of the investigator.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Lieske, M.D.

Open for enrollment

Contact information:

Angela Waits CCRP

7765293

Waits.Angela@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461787

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