An interventional study of Silver-nitrate coated catheter ("Catheter A") and Degradable silver particle-coated catheter ("Catheter B") in Bacteriuria, sponsored by Wellspect HealthCare. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Wellspect HealthCare (part of Dentsply Sirona) · Not applicable, Interventional, and Treatment
The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.
The study was designed as a prospective, randomized, double-blind, single-site study of 24 hours use of a silver coated antibacterial catheter, and 24 hours follow up, in subjects practicing intermittent catheterization.
Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →Wellspect HealthCare is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
First submitted before Wellspect HealthCare became part of Dentsply Sirona.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Catheterization with Catheter A, which releases silver ions into the urethra and urinary bladder upon catheterization,. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used. The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours).
Device: Silver-nitrate coated catheter ("Catheter A")
Catheterization with Catheter B, which releases both silver ions and degradable silver particles.. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used. The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours).
Device: Degradable silver particle-coated catheter ("Catheter B")
Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.
Total Bacteria Count Change From Baseline and After 24 Hours.
Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.
Time frame: Baseline and after 24 hours
Total Bacteria Count Change From Baseline and After 48 Hours.
Change from baseline (urine sample immediately before first catheterization with study product) and after 48 hours of intermittent catheterization. After the baseline sample the subject had 24 hours with study randomized catheter and then changed to 24 hours on non-study sterile intermittent catheterization.
Time frame: Baseline and after 48 hours
Total Bacteria Count Change From Baseline and After 7-14 Days.
Change from baseline and after 7-14 days. Change from baseline (urine sample immediately before first catheterization with study product) to after 7-14 days.
Time frame: Baseline and after 7-14 days
Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours
Escherichia coli mean bacteria count change from baseline (subjects with positive values) to after 12 hours. Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.
Time frame: After first catheterization with study product and after 12 hours
Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours
Escherichia coli mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.
Time frame: After first catheterization with study product and after 24 hours
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours
Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.
Time frame: After first catheterization with study product and after 12 hours
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours
Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.
Time frame: After first catheterization with study product and after 24 hours
Urine Silver Concentration Change From Baseline to 24 Hours
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: Baseline to 24 hours
Urine Silver Concentration Change From Baseline and After 48 Hours
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 48 hours
Urine Silver Concentration Change From Baseline to 7-14 Days
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: At baseline and after 7-14 days
Blood Silver Concentration Change From Baseline and After 24 Hours
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 24 hours
Blood Silver Concentration Change From Baseline and After 48 Hours
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 48 hours
Blood Silver Concentration Change From Baseline and After 7-14 Days
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
Time frame: After first catheterization with study product and after 7-14 days
| Milestone | Catheter A | Catheter B |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Total Bacteria Count Change From Baseline and After 24 Hours. | -62519 ± 9710767 | 57448 ± 9810360 |
Change from baseline (urine sample immediately before first catheterization with study product) and after 48 hours of intermittent catheterization. After the baseline sample the subject had 24 hours with study randomized catheter and then changed to 24 hours on non-study sterile intermittent catheterization.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Total Bacteria Count Change From Baseline and After 48 Hours. | -1980704 ± 6599515 | 2072657 ± 11673736 |
Change from baseline and after 7-14 days. Change from baseline (urine sample immediately before first catheterization with study product) to after 7-14 days.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Total Bacteria Count Change From Baseline and After 7-14 Days. | 12477797 ± 10769480 | 18650000 ± 6851389 |
Escherichia coli mean bacteria count change from baseline (subjects with positive values) to after 12 hours. Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours | 0 ± 0 | 74500 ± 166587 |
Escherichia coli mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours | 5113750 ± 10227500 | -4124000 ± 9221544 |
Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours | 333 ± 612 | 20997300 |
Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values). Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.
| CFU/mL | Catheter A | Catheter B |
|---|---|---|
| Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours | -51498 ± 73684 | 20999983 |
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
| nmol Ag/mmol creatinine | Catheter A | Catheter B |
|---|---|---|
| Urine Silver Concentration Change From Baseline to 24 Hours | 5.15 ± 9.70 | 6.20 ± 5.26 |
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
| nmol Ag/mmol creatinine | Catheter A | Catheter B |
|---|---|---|
| Urine Silver Concentration Change From Baseline and After 48 Hours | -0.02 ± 0.11 | -0.02 ± 0.12 |
Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up. Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
| nmol Ag/mmol creatinine | Catheter A | Catheter B |
|---|---|---|
| Urine Silver Concentration Change From Baseline to 7-14 Days | 0.39 ± 0.53 | 0.10 ± 0.24 |
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
| nmol Ag/L | Catheter A | Catheter B |
|---|---|---|
| Blood Silver Concentration Change From Baseline and After 24 Hours | -.02 ± 0.28 | 0.39 ± 0.22 |
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
| nmol Ag/L | Catheter A | Catheter B |
|---|---|---|
| Blood Silver Concentration Change From Baseline and After 48 Hours | 0.02 ± 0.48 | 0.27 ± 0.25 |
Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).
| nmol Ag/L | Catheter A | Catheter B |
|---|---|---|
| Blood Silver Concentration Change From Baseline and After 7-14 Days | 0.31 ± 0.54 | -0.04 ± 0.61 |
Collected over 3 days. The study was performed during 3 days starting with a wash out during one day, then the randomized study product was used for one day, ending with a wash out day with a non-study product.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Catheter A | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Catheter B | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Catheter A | Catheter B |
|---|---|---|
| HeadacheGeneral disorders | 0/10 | 2/10 |
| FeverGeneral disorders | 0/10 | 1/10 |
| Rash in the right legSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Frequency of micturation increasedRenal and urinary disorders | 1/10 | 0/10 |
| Wrist painMusculoskeletal and connective tissue disorders | 1/10 | 0/10 |
| Symptoms of urinary tract infectionRenal and urinary disorders | 1/10 | 0/10 |
| Sensation of preassure in the bladderRenal and urinary disorders | 0/10 | 1/10 |
| Age, Continuous(years) | Catheter A | Catheter B | Total |
|---|---|---|---|
| Mean | 49 ± 8 | 40 ± 8 | 44 ± 9 |
| Sex: Female, Male(Participants) | Catheter A | Catheter B | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 9 | 8 | 17 |
| Region of Enrollment(participants) | Catheter A | Catheter B | Total |
|---|---|---|---|
| Sweden | 10 | 10 | 20 |
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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