Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

Overview

In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence. The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2023

Interventions

  • Drug: Ure-Na
    • Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) Treatment will continue for approximately 1 month.

Arms, Groups and Cohorts

  • Experimental: Open label
    • The study provides for a single group, which will be its own control (pre/post intervention study). Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) for 1 month

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in urine output at 1 week and 1 Month
    • Time Frame: 1 week and 1 month
    • variation in 24-hour diuresis and urine biochemistry

Participating in This Clinical Trial

Inclusion Criteria

  • 18 to 60 years of age – High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.) – Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months) Exclusion Criteria:

  • Patient does not meet 1 of the 3 inclusion criteria – Pregnancy or breastfeeding – Lack of understanding about the protocol and effects of Ure-Na – Expected inability to adequately increase fluid intake on Ure-Na

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Provider of Information About this Clinical Study
    • Sponsor

References

Dion M, Ankawi G, Chew B, Paterson R, Sultan N, Hoddinott P, Razvi H. CUA guideline on the evaluation and medical management of the kidney stone patient – 2016 update. Can Urol Assoc J. 2016 Nov-Dec;10(11-12):E347-E358. doi: 10.5489/cuaj.4218. Epub 2016 Nov 10.

Borghi L, Meschi T, Amato F, Briganti A, Novarini A, Giannini A. Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study. J Urol. 1996 Mar;155(3):839-43.

Soupart A, Coffernils M, Couturier B, Gankam-Kengne F, Decaux G. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADH. Clin J Am Soc Nephrol. 2012 May;7(5):742-7. doi: 10.2215/CJN.06990711. Epub 2012 Mar 8.

Berl T. Impact of solute intake on urine flow and water excretion. J Am Soc Nephrol. 2008 Jun;19(6):1076-8. doi: 10.1681/ASN.2007091042. Epub 2008 Mar 12.

Decaux G, Brimioulle S, Genette F, Mockel J. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by urea. Am J Med. 1980 Jul;69(1):99-106.

Verbalis JG, Baldwin EF, Neish PN, Robinson AG. Effect of protein intake and urea on sodium excretion during inappropriate antidiuresis in rats. Metabolism. 1988 Jan;37(1):46-54.

Nayan M, Elkoushy MA, Andonian S. Variations between two 24-hour urine collections in patients presenting to a tertiary stone clinic. Can Urol Assoc J. 2012 Feb;6(1):30-3. doi: 10.5489/cuaj.11131.

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