An interventional study of Lit control pHDown in Stent Complications, sponsored by Devicare S.L.. Completed at 9 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Devicare S.L. · Not applicable, Interventional, and Prevention
This study evaluates the effectivity in urinary pH Control and the prevention of calcification in Double J stent using a device combined with the intake of dietary supplements. Every patient will receive hygienic-dietary indications.
Patients will also take one out of the three dietary supplements regarded within the study (pH Up, pH Down and Cysteine) to control the adequate pH level, always following medical indications.
Several studies have shown the importance of urinary pH Control (pHv) to determine the frequency of stent incrustation, this measure being a variable to be taken into account in the management of catheterized patients. However, the level of pHv is influenced by multiple factors, so its routine control is difficult to interpret. The nucleation pH (pHn) was described on 1999: the pH where the incrustation starts to form. In his study he observed that the pH of the patients who developed a stent blockage and the pH of those who were not very similar (7.46 and 7.38 respectively), but observed that the pHv of the patients who did not have incrustations was much lower and therefore had a much wider safety margin.
As already mentioned, pHv is influenced by different factors, but it is especially sensitive to diet. For this reason, hygienic and dietetic interventions (exercise, diet, fluid intake, etc.) are one of the preventive measures of incrustation of the stent of great utility, although its effectiveness is subject to patient adherence.
Lit-control®pH Down is a dietary supplement with an acidifying effect on urine, which helps in the prevention of complications arising from the alkalinization of urine. It contains L-methionine, phytin (calcium-magnesium phytate salt), zinc and vitamin A. The two active components in pHv acidification are L-methionine and phytin,while zinc and vitamin A increase the action of phytin. Specifically, zinc favors the affinity of its affinity for calcium phosphate and vitamin A prevents its degradation by alkaline phosphatase.
L-methionine is an essential amino acid that plays an important role in metabolic processes. It is normally acquired through food and absorbed in the small intestine to be metabolized in the liver via cysteine to sulphate and protons. Consequently, its administration produces a significant reduction of urinary pH.
According to the European Association of Urology (UAE), urinary acidification with L-methionine up to pH 5.8 - 6.2 is recommended as a therapeutic measure for calculations of struvite, calcium phosphate and ammonium urate at doses of 600- 1500 mg / day. This recommendation is based on the results observed in 1996, where an acidification of the pH of the urine of the patients was observed from 7.5 to 5.5 after the administration of 1500-3000 mg / day (3-6 capsules) of 500mg / day. Also in the study of Hesse 1999 a significant reduction in urinary pH was observed up to pH = 6.0 after the administration of a single dose of 1500 mg of L-methionine, maintaining this effect for 24h. In addition, a significant reduction was observed versus the control group in terms of the relative supersaturation for struvite and brushite in the urine of 24h. In another more recent study, the authors studied the circadian course of urinary pH after the administration of 1500 mg of L-methionine. They observed a strong decrease in urinary pH up to 2h after the administration of the amino acid that remained at significantly low levels for 8h, resulting in a pH level for 24h between 5.98 and 6.32. Therefore, in order to guarantee therapeutic doses of L-Methionine (1500mg / day), the Lit-control®pH Down regimen to follow would be equivalent to 3 capsules per day (500 mg / capsule).
On the other hand, the device Lit-control® pH Meter is a medical device that allows patients to self-monitor their pHv daily in their own home, allowing a thorough control of the pH and the level of risk of incrustation. The device has been validated for use in lithiasic patients, with applicability in the treatment of other urological pathologies related to the acid-base balance of urine, calcifications of urinary stents, cystitis, urinary tract infections, painful bladder syndrome and bladder hyperactive
The objective of this study is to evaluate the effectiveness of the food supplement Lit-control®pH Down in the prevention of double J stent incrustation and in the control of urinary pH together with the use of the device Lit-control® pH meter
Devicare S.L. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary supplement : Lit-Control® pH Down * Pharmaceutical form: capsules * Administration : oral * Dose: 3 capsules/day. • Sanitary product : Lit-Control® pH Meter * In vitro diagnosis sanitary product * Use:Urinary pH evaluation
Combination Product: Lit control pHDown
Placebo: * Pharmaceutical form: capsules * Administration : oral * Dose: 3 capsules/day. • Sanitary product : Lit-Control® pH Meter * In vitro diagnosis sanitary product * Use:Urinary pH evaluation
Combination Product: Lit control pHDown
Patients within the experimental arm will receive dietary supplement Lit-control®pH Down to help them keep their urinary pH in the adequate levels, being these considered as the preventive ones to avoid stent calcification (pH\<6.2) being the 3 capsule per day indication. On the other hand, the control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics. Both arms wil use Lit-Control® pH Meter device to keep self- control of the urinary pH; also, both will receive the same hygienic-dietary indications about the care of the stent.
Incrustation Score
0 (No incrustation); 1(Sporadic incrustation less than 1-2 mm); 2 (Wide area calcifications more than 1-2 mm) ; 3 (Total obstruction)
Time frame: 2 days
Urinary pH level
Time frame: 2 times/day
Stent implant cause
Medical evaluation and diagnosis leading to stent implant
Time frame: 2 months
Self-control below values 6.2
Time frame: 2 times/day
Anatomic alterations on the urinary system
Medical evaluation on the different alterations present in the urinary system.
Time frame: 2 months
Previous uropathic obstructive incidence
Number of obstructions in the past two months.
Time frame: 2 months
Date of past stent implants
Time frame: 2 months
pH control: Total time
Time frame: 2 times/day
2 hours urine analysis :Fasting
Time frame: 2 hours
Urine culture
Time frame: 48 hours
Complications associated with stent implant
Time frame: 2 months
Treatment adherence
The clinical will evaluate the patient treatment adherence by means of Morisky-Green test
Time frame: 2 months
Stent extraction data
Possibility of complications during the extraction, date of extraction, intervention type, intervention duration
Time frame: 2 months
Blockage risk factor
Evaluation by clinical evaluation
Time frame: 1 month prior intervention
Date of stent extraction
Time frame: 2 months
Type of previous stent
Description of the previous stent
Time frame: 2 months
Number of different symptoms associated with the previous calcification
Different symptomatology associated with the previous calcification
Time frame: 2 months
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Devicare S.L.