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).

Devicare S.L.60 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cystinuria

Interventions

Lit-control®pH MeterDEVICE

Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.

Reactive stripsDIAGNOSTIC_TEST

Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years old. * Cystinuric patients, with or without urinary lithiasis at the time of inclusion. * Patients who accept their participation in the study and give their informed consent. Exclusion Criteria: * Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.

Locations (1)

Fundacio Puigvert

Barcelona, Spain

Outcomes

Primary Outcomes

Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.

Urinary pH measurement

Time frame: 183 measurements (morning) in 6 months.

Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.

Urinary pH measurement

Time frame: 183 measurements (afternoon) in 6 months.

Measurement of the volume of crystalluria.

volume of crystalluria

Time frame: 1 measurement at the moment of enrollment

Measurement of the volume of crystalluria.

volume of crystalluria

Time frame: 1 measurement at 6 months

Blood: DNA extraction.

Extraction of DNA for genetic study of mutations for cystinuria.

Time frame: 1 measurement at the moment of enrollment

Sediment analysis for the determination of urinary infection.

Sediment analysis for the determination of Ulcer Index (UI)

Time frame: 1 measurement at the moment of enrollment

Sediment analysis for the determination of urinary infection.

Sediment analysis for the determination of UI

Time frame: 1 measurement at 6 months

Total time within the margins established as safe in the pH control (months).

Amount of time within the pH margins established as safe

Time frame: 1 measurement through study completion [up to 6 months]

Data from ClinicalTrials.gov

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Adherence level in pH measurements

% compliance of the pH measurements

Time frame: Through study completion, fraction of pH measurements on the total possible. [up to 6 months]

Adherence level to treatment

% of the intakes of the medication.

Time frame: Through study completion, fraction of intakes on the total possible. [up to 6 months]

Total number of adverse events reported.

Amount of adverse events reported

Time frame: Through study completion, number of events. [up to 6 months]

Blood Analysis. Glucose

Glucose in mmol/L