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| Name | Class |
|---|---|
| Clever Instruments S.L. | INDUSTRY |
| Fundacio Puigvert | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lit-control®pH Meter | Experimental | The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the Lit-control®pH Meter device. |
|
| Reactive strips | Placebo Comparator | The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the reactive strips. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lit-control®pH Meter | Device | Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring. | Urinary pH measurement | 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 | 183 measurements (afternoon) in 6 months. |
| Measurement of the volume of crystalluria. | volume of crystalluria | 1 measurement at the moment of enrollment |
| Measurement of the volume of crystalluria. | volume of crystalluria | 1 measurement at 6 months |
| Blood: DNA extraction. | Extraction of DNA for genetic study of mutations for cystinuria. | 1 measurement at the moment of enrollment |
| Sediment analysis for the determination of urinary infection. | Sediment analysis for the determination of Ulcer Index (UI) | 1 measurement at the moment of enrollment |
| Sediment analysis for the determination of urinary infection. | Sediment analysis for the determination of UI | 1 measurement at 6 months |
| Total time within the margins established as safe in the pH control (months). |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic and anthropometric questionnaire. | Family and personal background and general data (sex, age, etc.). | 1 day of enrollment |
| Patient satisfaction questionnaire with the pH measurement method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oriol Angerri, MD | Fundacio Puigvert | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacio Puigvert | Barcelona | 08025 | Spain |
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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).
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The process of randomization, either device use or use of strips, will be masked until the moment it is delivered to the patient. The random assignment to each product will be made through lists created by an ad hoc computer program.
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| Reactive strips | Diagnostic Test | Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips. |
|
Amount of time within the pH margins established as safe |
| 1 measurement through study completion [up to 6 months] |
| Adherence level in pH measurements | % compliance of the pH measurements | 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. | 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 | Through study completion, number of events. [up to 6 months] |
| Blood Analysis. Glucose | Glucose in mmol/L | Change from Baseline measurement at 6 months |
| Blood Analysis. Calcium phosphate | calcium phosphate in µmol/L | Change from Baseline measurement at 6 months |
| Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI) | estimated FG CKD-EPI | Change from Baseline measurement at 6 months |
| Blood Analysis. Cystatin | cystatin in mg/L (to be measured only if estimated FG> 45 or \ | Change from Baseline measurement at 6 months |
| Blood Analysis. Creatinine | creatinine in µmol/L | Change from Baseline measurement at 6 months |
| Blood Analysis. Urate | urate in μmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Weight | Weight in kg | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Size | Size in m | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Urinary volume | Urinary volume in L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Calcium phosphate | calcium phosphate in µmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Citrate | citrate in μmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Urate | urate in μmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Magnesium | magnesium in μmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Sodium | sodium in μmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. BMI | weight and height will be combined to report BMI in kg/m^2 | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Potassium | potassium in μmol/L | Change from Baseline measurement at 6 months |
| 24h Urine Analysis. Urea | urea in µmol/L | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Schedule | First urine of the morning (totality) for the study of crystalluria. Patient will provide the last hour of urination and hour of urine obtention in the morning. | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Crystalline volume | overall crystalline volume (μm3 / mL) | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Crystals | type and number of crystals (crystals / μL) | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Urine volume | urine volume in L | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. pH | pH | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Size | size in μm | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Density | Density in mg / mL. | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Aggregation | aggregation | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Twinning | twinning | Change from Baseline measurement at 6 months |
| Urine for the study of crystalluria. Quotient | Quotient albumin / creatinine | Change from Baseline measurement at 6 months |
Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)
| 3 times in 6 months |
| Physician satisfaction questionnaire with the pH measurement method | Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied | 3 times in 6 months |
| ID | Term |
|---|---|
| D003555 | Cystinuria |
| ID | Term |
|---|---|
| D000608 | Renal Aminoacidurias |
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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