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Clinical Trial Summary

This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care).


Clinical Trial Description

Cystinuria is a disease of autosomal recessive inheritance. This disease belongs to the so-called orphan diseases although its prevalence may change depending on the country.

It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.

The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03539926
Study type Interventional
Source Devicare S.L.
Contact
Status Active, not recruiting
Phase N/A
Start date April 9, 2018
Completion date February 2019

See also
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Active, not recruiting NCT02910531 - Lipoic Acid Supplement for Cystine Stone Phase 2
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Not yet recruiting NCT05058859 - Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics Phase 2
Completed NCT00381849 - Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones Phase 1/Phase 2
Completed NCT03836144 - Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria