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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.

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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.

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.


Condition or disease Intervention/treatment Phase
Stent Complications Combination Product: Lit control pHDown Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
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
Official Title: 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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : July 9, 2018
Actual Study Completion Date : July 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. 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)

  2. Urinary pH level [ Time Frame: 2 times/day ]
  3. Stent implant cause [ Time Frame: 2 months ]
    Medical evaluation and diagnosis leading to stent implant

  4. Self-control below values 6.2 [ Time Frame: 2 times/day ]

Secondary Outcome Measures :
  1. Anatomic alterations on the urinary system [ Time Frame: 2 months ]
    Medical evaluation on the different alterations present in the urinary system.

  2. Previous uropathic obstructive incidence [ Time Frame: 2 months ]
    Number of obstructions in the past two months.

  3. Date of past stent implants [ Time Frame: 2 months ]
  4. pH control: Total time [ Time Frame: 2 times/day ]
  5. 2 hours urine analysis :Fasting [ Time Frame: 2 hours ]
  6. Urine culture [ Time Frame: 48 hours ]
  7. Complications associated with stent implant [ Time Frame: 2 months ]
  8. Treatment adherence [ Time Frame: 2 months ]
    The clinical will evaluate the patient treatment adherence by means of Morisky-Green test

  9. Stent extraction data [ Time Frame: 2 months ]
    Possibility of complications during the extraction, date of extraction, intervention type, intervention duration

  10. Blockage risk factor [ Time Frame: 1 month prior intervention ]
    Evaluation by clinical evaluation

  11. Date of stent extraction [ Time Frame: 2 months ]
  12. Type of previous stent [ Time Frame: 2 months ]
    Description of the previous stent

  13. Number of different symptoms associated with the previous calcification [ Time Frame: 2 months ]
    Different symptomatology associated with the previous calcification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343275


Locations
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Spain
Hospital Universitario de Valme
Sevilla, Andalucía, Spain
Hospital Universitari de Bellvitge
Hospitalet De Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de compostela, Galicia, Spain, 15706
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Fundació Puigvert
Barcelona, Spain, 08025
Hospital Clínico Universitario San Cecilio
Granada, Spain, 18012
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
Sponsors and Collaborators
Devicare S.L.
Clever Instruments S.L.
  Study Documents (Full-Text)

Documents provided by Devicare S.L.:
Study Protocol  [PDF] May 17, 2017


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Responsible Party: Devicare S.L.
ClinicalTrials.gov Identifier: NCT03343275     History of Changes
Other Study ID Numbers: DEV-LCD-02-17
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Devicare S.L.:
Stent, incrustation, pH Control