Stent ComplicationsNCT03343275
Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.
A study of Stent Complications, run by Devicare S.L. at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Complications
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 9 sitesSpain
- Study dates
- 13 Dec 2017to 9 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Fundació Puigvert
Barcelona, 08025
Hospital Clínico Universitario San Cecilio
Granada, 18012
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital Universitario La Paz
Madrid, 28046
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, 15706
Hospital Universitario de Valme
Seville, Andalusia
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Hospital Universitario Rio Hortega
Valladolid, 47012
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312
About this study
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
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.
Read the 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
- Conditions
- Stent Complications
- Being tested
- Lit control pHDown
- Keywords
- Stent, incrustation, pH Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lit control pHDownCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Combination Product: Lit control pHDown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 days
Urinary pH level
Measured: 2 times/day
Stent implant cause
Medical evaluation and diagnosis leading to stent implant
Measured: 2 months
Self-control below values 6.2
Measured: 2 times/day
Secondary outcomes (13)
Anatomic alterations on the urinary system
Medical evaluation on the different alterations present in the urinary system.
Measured: 2 months
Previous uropathic obstructive incidence
Number of obstructions in the past two months.
Measured: 2 months
Date of past stent implants
Measured: 2 months
pH control: Total time
Measured: 2 times/day
2 hours urine analysis :Fasting
Measured: 2 hours
Urine culture
Measured: 48 hours
Complications associated with stent implant
Measured: 2 months
Treatment adherence
The clinical will evaluate the patient treatment adherence by means of Morisky-Green test
Measured: 2 months
Stent extraction data
Possibility of complications during the extraction, date of extraction, intervention type, intervention duration
Measured: 2 months
Blockage risk factor
Evaluation by clinical evaluation
Measured: 1 month prior intervention
Date of stent extraction
Measured: 2 months
Type of previous stent
Description of the previous stent
Measured: 2 months
Number of different symptoms associated with the previous calcification
Different symptomatology associated with the previous calcification
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Dec 2017
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stent ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Devicare S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343275
- Sponsor's protocol ID
- DEV-LCD-02-17
- Status last verified
- Jul 2018
- First submitted
- 2 Nov 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32503502
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03343275
- Acronym / sponsor ID
- DEV-LCD-02-17
- Conditions
- Stent Complications
- Keywords
- Stent, incrustation, pH Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Devicare S.L.Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Combination Product: Lit control pHDownDietary 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 |
| Placebo | Placebo comparator | Combination Product: Lit control pHDownPlacebo: * Pharmaceutical form: capsules * Administration : oral * Dose: 3 capsules/day. • Sanitary product : Lit-Control® pH Meter * In vitro diagnosis sanitary product * Use:Urinary pH evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lit control pHDownPatients 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. | Combination product | Experimental, Placebo |
Primary outcome
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
13 secondary outcomes
Anatomic alterations on the urinary system
Time frame: 2 months
Previous uropathic obstructive incidence
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
Time frame: 2 months
Stent extraction data
Time frame: 2 months
Blockage risk factor
Time frame: 1 month prior intervention
Date of stent extraction
Time frame: 2 months
Type of previous stent
Time frame: 2 months
Number of different symptoms associated with the previous calcification
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Derived from this study: PubMed 32503502Torrecilla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stent Complications, run by Devicare S.L. at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incrustation Score (time frame: 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.