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: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: April 2023
- 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
- 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
- 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
- Lead Sponsor
- Centre hospitalier de l’Université de Montréal (CHUM)
- Provider of Information About this Clinical Study
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