Clinical trial NCT03539926: 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).
Official title: Randomized, Controlled and Opened Trial on the Impact of the Use of a pH-Meter on the Domiciliary Control of the Urinary pH as Adjuvant to the Treatment of Cystinuric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystinuria
Keywords: Cystinuria
pH Control
Lead sponsor: Devicare S.L.
Sponsor class: INDUSTRY
Collaborators: name: Clever Instruments S.L.
name: Fundacio Puigvert
First posted: 2018-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive the product for home pH monitoring, but they will keep following the doctor's recommendations indicated in the usual clinical practice.

The proportion of patients will be 1: 1 between the study group (Lit-control®pH Meter) and the control group (test strips).
Primary purpose: OTHER

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
timeFrame: 183 measurements (morning) in 6 months.
measure: Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
timeFrame: 183 measurements (afternoon) in 6 months.
measure: Measurement of the volume of crystalluria.
timeFrame: 1 measurement at the moment of enrollment
measure: Measurement of the volume of crystalluria.
timeFrame: 1 measurement at 6 months
measure: Blood: DNA extraction.
timeFrame: 1 measurement at the moment of enrollment
measure: Sediment analysis for the determination of urinary infection.
timeFrame: 1 measurement at the moment of enrollment
measure: Sediment analysis for the determination of urinary infection.
timeFrame: 1 measurement at 6 months
measure: Total time within the margins established as safe in the pH control (months).
timeFrame: 1 measurement through study completion [up to 6 months]
measure: Adherence level in pH measurements
timeFrame: Through study completion, fraction of pH measurements on the total possible. [up to 6 months]
measure: Adherence level to treatment
timeFrame: Through study completion, fraction of intakes on the total possible. [up to 6 months]
measure: Total number of adverse events reported.
timeFrame: Through study completion, number of events. [up to 6 months]
measure: Blood Analysis. Glucose
timeFrame: Change from Baseline measurement at 6 months
measure: Blood Analysis. Calcium phosphate
timeFrame: Change from Baseline measurement at 6 months
measure: Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)
timeFrame: Change from Baseline measurement at 6 months
measure: Blood Analysis. Cystatin
timeFrame: Change from Baseline measurement at 6 months
measure: Blood Analysis. Creatinine
timeFrame: Change from Baseline measurement at 6 months
measure: Blood Analysis. Urate
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Weight
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Size
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Urinary volume
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Calcium phosphate
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Citrate
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Urate
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Magnesium
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Sodium
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. BMI
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Potassium
timeFrame: Change from Baseline measurement at 6 months
measure: 24h Urine Analysis. Urea
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Schedule
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Crystalline volume
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Crystals
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Urine volume
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. pH
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Size
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Density
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Aggregation
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Twinning
timeFrame: Change from Baseline measurement at 6 months
measure: Urine for the study of crystalluria. Quotient
timeFrame: Change from Baseline measurement at 6 months
Secondary outcomes:
measure: Sociodemographic and anthropometric questionnaire.
timeFrame: 1 day of enrollment
measure: Patient satisfaction questionnaire with the pH measurement method
timeFrame: 3 times in 6 months
measure: Physician satisfaction questionnaire with the pH measurement method
timeFrame: 3 times in 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacio Puigvert
Study officials:
affiliation: Fundacio Puigvert
name: Oriol Angerri, MD
role: PRINCIPAL_INVESTIGATOR
References: