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

NCT03343275 | Completed

• 1 other identifier: DEV-LCD-02-17
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 9

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.

Conditions

Stent Complications

Keywords

Stent, incrustation, pH Control

Outcome Measures

Primary Outcomes (4)

• 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)

  2 days

• Urinary pH level

  2 times/day

• Stent implant cause

  Medical evaluation and diagnosis leading to stent implant

  2 months

• Self-control below values 6.2

  2 times/day

Secondary Outcomes (13)

• Anatomic alterations on the urinary system

  2 months

• Previous uropathic obstructive incidence

  2 months

• Date of past stent implants

  2 months

• pH control: Total time

  2 times/day

• 2 hours urine analysis :Fasting

  2 hours

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lit control pHDown COMBINATION_PRODUCT

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.

Experimental; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Devicare S.L.: lead
• Clever Instruments S.L.: collaborator

Study Sites (9)

Hospital Universitario de Valme

Seville, Andalusia, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Fundació Puigvert

Barcelona, 08025, Spain

Location

Hospital Clínico Universitario San Cecilio

Granada, 18012, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Related Publications (1)

• Torrecilla C, Fernandez-Concha J, Cansino JR, Mainez JA, Amon JH, Costas S, Angerri O, Emiliani E, Arrabal Martin MA, Arrabal Polo MA, Garcia A, Reina MC, Sanchez JF, Budia A, Perez-Fentes D, Grases F, Costa-Bauza A, Cune J. Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a multicenter, placebo controlled, double blind, randomized clinical trial. BMC Urol. 2020 Jun 5;20(1):65. doi: 10.1186/s12894-020-00633-2.

  PMID: 32503502 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 17, 2017
• Study Start: December 13, 2017
• Primary Completion: July 9, 2018
• Study Completion: July 9, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

ES (9)