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Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343275
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Clever Instruments S.L.
Information provided by (Responsible Party):
Devicare S.L.

Tracking Information
First Submitted Date  ICMJE November 2, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date July 11, 2018
Actual Study Start Date  ICMJE December 13, 2017
Actual Primary Completion Date July 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Incrustation Score [ Time Frame: 2 days ]
    0 (No incrustation); 1(Sporadic incrustation less than 1-2 mm); 2 (Wide area calcifications more than 1-2 mm) ; 3 (Total obstruction)
  • Urinary pH level [ Time Frame: 2 times/day ]
  • Stent implant cause [ Time Frame: 2 months ]
    Medical evaluation and diagnosis leading to stent implant
  • Self-control below values 6.2 [ Time Frame: 2 times/day ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • Incrustation Score [ Time Frame: 2 days ]
    0 (No incrustation); 1(Sporadic incrustation less than 1-2 mm); 2 (Wide area calcifications more than 1-2 mm) ; 3 (Total obstruction)
  • Urinary pH level [ Time Frame: 2 times/day ]
  • Cathether implant cause [ Time Frame: 2 months ]
    Medical evaluation and diagnosis leading to catheter implant
  • Self-control below values 6.2 [ Time Frame: 2 times/day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Anatomic alterations on the urinary system [ Time Frame: 2 months ]
    Medical evaluation on the different alterations present in the urinary system.
  • Previous uropathic obstructive incidence [ Time Frame: 2 months ]
    Number of obstructions in the past two 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 [ Time Frame: 2 months ]
    The clinical will evaluate the patient treatment adherence by means of Morisky-Green test
  • Stent extraction data [ Time Frame: 2 months ]
    Possibility of complications during the extraction, date of extraction, intervention type, intervention duration
  • Blockage risk factor [ Time Frame: 1 month prior intervention ]
    Evaluation by clinical evaluation
  • Date of stent extraction [ Time Frame: 2 months ]
  • Type of previous stent [ Time Frame: 2 months ]
    Description of the previous stent
  • Number of different symptoms associated with the previous calcification [ Time Frame: 2 months ]
    Different symptomatology associated with the previous calcification
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • Anatomic alterations on the urinary system [ Time Frame: 2 months ]
    Medical evaluation on the different alterations present in the urinary system.
  • Previous uropathic obstructive incidence [ Time Frame: 2 months ]
    Number of obstructions in the past two months.
  • Date of past catheter 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 cathether implant [ Time Frame: 2 months ]
  • Treatment adherence [ Time Frame: 2 months ]
    The clinical will evaluate the patient treatment adherence by means of Morisky-Green test
  • Cathether extraction data [ Time Frame: 2 months ]
    Possibility of complications during the extraction, date of extraction, intervention type, intervention duration
  • Blockage risk factor [ Time Frame: 1 month prior intervention ]
    Evaluation by clinical evaluation
  • Date of catheter extraction [ Time Frame: 2 months ]
  • Type of previous catheter [ Time Frame: 2 months ]
    Description of the previous catheter
  • Number of different symptoms associated with the previous catheterization [ Time Frame: 2 months ]
    Different sintomatology associated with the previous catheterization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.
Official Title  ICMJE Multicenter, Controlled and Randomized Clinical Trial to Evaluate the Combined Use of a Medical Device and a Food Supplement in the Control of Urinary pH in Patients With an Implanted Double Pigtail Stent
Brief Summary

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.

Detailed Description

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Adults attending urology/nephrology consultation whom have been recently implanted a double J stent or have its implantation programmed and are able of taking care in urinary pH self-control.
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Stent Complications
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Experimental

    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
    Intervention: Combination Product: Lit control pHDown
  • Placebo Comparator: Placebo

    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
    Intervention: Combination Product: Lit control pHDown
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2017)
105
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 9, 2018
Actual Primary Completion Date July 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18 years old
  • Patients which have been recently implanted a Double J stent (less than a week implant) or who have planned their implant and have been recommended with pH control to avoid incrustation/calcification.
  • Patients who accept their participation in the study and give their informed consent

Exclusion Criteria:

  • Patients with base pathologies wich , based on clinical criteria, aren´t sensitive about the study dietary supplement indications.
  • Patients which have programmed the stent extraction 3 weeks before base visit.
  • Uric and cystinuric patients which requires pH control different from the established study protocol .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03343275
Other Study ID Numbers  ICMJE DEV-LCD-02-17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Devicare S.L.
Study Sponsor  ICMJE Devicare S.L.
Collaborators  ICMJE Clever Instruments S.L.
Investigators  ICMJE Not Provided
PRS Account Devicare S.L.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP