BacteriuriaNCT01143116

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

A study testing Silver-nitrate coated catheter ("Catheter A") and Degradable silver particle-coated catheter ("Catheter B") in people with Bacteriuria, run by Wellspect HealthCare at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bacteriuria
What is being tested?: Silver-nitrate coated catheter ("Catheter A") and Degradable silver particle-coated catheter ("Catheter B")
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2010to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Provision of informed consent
Female/male aged 18 years and over
Practicing intermittent catheterization at least 4 times daily for at least 6 weeks
A minimum of 104 CFU of bacteriuria

Who cannot join

Ongoing, symptomatic UTI at enrollment
Known urethral stricture
Basic tumorous disease
Previous prostate surgery
Subjects known to be immunocompromised e.g. HIV or diabetes
Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start

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Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
Pregnancy or breast feeding
Previous enrolment or randomisation of treatment in the present study
Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator
Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry, Shropshire, SY10 7AG

Other trials in United Kingdom

About this study

Read the detailed description

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.

Conditions: Bacteriuria
Being tested: Silver-nitrate coated catheter ("Catheter A"), Degradable silver particle-coated catheter ("Catheter B")
Medical subject headings: Bacteriuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Silver-nitrate coated catheter ("Catheter A")Device
Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.
Degradable silver particle-coated catheter ("Catheter B")Device
Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.

Study groups in NCT01143116
Study group	Role	What they receive
Catheter A	Experimental	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). Receives: Device: Silver-nitrate coated catheter ("Catheter A")
Catheter B	Experimental	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). Receives: Device: Degradable silver particle-coated catheter ("Catheter B")

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 7-14 days

Secondary outcomes (10)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: After first catheterization with study product and after 7-14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2011

First posted14 Jun 2010 (estimated)
Study startNov 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BacteriuriaStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01143116
Sponsor's protocol ID: YA-ABC-0003
Status last verified: May 2022
First submitted: 9 Jun 2010
Last updated: 3 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
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Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Disease
RecruitingPhase 1
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
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RecruitingObservational study
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter

All Bacteriuria trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
ClinicalTrials.gov ID: NCT01143116
Acronym / sponsor ID: YA-ABC-0003
Conditions: Bacteriuria
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Wellspect HealthCareIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 14 Jun 2010 (estimated)
Results: Posted 3 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Catheter A	Experimental	Device: Silver-nitrate coated catheter ("Catheter A")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).
Catheter B	Experimental	Device: Degradable silver particle-coated catheter ("Catheter B")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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provision of informed consent
Female/male aged 18 years and over
Practicing intermittent catheterization at least 4 times daily for at least 6 weeks
A minimum of 104 CFU of bacteriuria

Key exclusion criteria (11 listed)

Ongoing, symptomatic UTI at enrollment
Known urethral stricture
Basic tumorous disease
Previous prostate surgery
Subjects known to be immunocompromised e.g. HIV or diabetes

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
Silver-nitrate coated catheter ("Catheter A")Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.	Device	Catheter A
Degradable silver particle-coated catheter ("Catheter B")Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.	Device	Catheter B

Primary outcome

Total Bacteria Count Change From Baseline and After 24 Hours.
Time frame: 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.
Total Bacteria Count Change From Baseline and After 48 Hours.
Time frame: 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.
Total Bacteria Count Change From Baseline and After 7-14 Days.
Time frame: 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.

10 secondary outcomes

Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours
Time frame: After first catheterization with study product and after 12 hours
Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours
Time frame: After first catheterization with study product and after 24 hours
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours
Time frame: After first catheterization with study product and after 12 hours
Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours
Time frame: After first catheterization with study product and after 24 hours
Urine Silver Concentration Change From Baseline to 24 Hours
Time frame: Baseline to 24 hours
Urine Silver Concentration Change From Baseline and After 48 Hours
Time frame: After first catheterization with study product and after 48 hours
Urine Silver Concentration Change From Baseline to 7-14 Days
Time frame: At baseline and after 7-14 days
Blood Silver Concentration Change From Baseline and After 24 Hours
Time frame: After first catheterization with study product and after 24 hours
Blood Silver Concentration Change From Baseline and After 48 Hours
Time frame: After first catheterization with study product and after 48 hours
Blood Silver Concentration Change From Baseline and After 7-14 Days
Time frame: After first catheterization with study product and after 7-14 days

Results and safety

Results posted to the registry on 3 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Catheter A	10	10
Catheter B	10	10

Primary outcome: Total Bacteria Count Change From Baseline and After 24 Hours.

Time frame: Baseline and after 24 hours. Mean (Standard Deviation). Unit: CFU/mL

Measure	Catheter A n = 10	Catheter B n = 10
Value	-62519 (9710767)	57448 (9810360)

Catheter A: p = 0.6250, Wilcoxon (Mann-Whitney)
Catheter B: p = 0.7500, Wilcoxon (Mann-Whitney)

Population analysed: ITT

Primary outcome: Total Bacteria Count Change From Baseline and After 48 Hours.

Time frame: Baseline and after 48 hours. Mean (Standard Deviation). Unit: CFU/mL

Measure	Catheter A n = 10	Catheter B n = 10
Value	-1980704 (6599515)	2072657 (11673736)

Catheter A: p = 0.8750, Wilcoxon (Mann-Whitney)
Catheter B: p = 0.6250, Wilcoxon (Mann-Whitney)

Population analysed: ITT

Primary outcome: Total Bacteria Count Change From Baseline and After 7-14 Days.

Time frame: Baseline and after 7-14 days. Mean (Standard Deviation). Unit: CFU/mL

Measure	Catheter A n = 10	Catheter B n = 10
Value	12477797 (10769480)	18650000 (6851389)

Catheter A: p = 0.0254, Wilcoxon (Mann-Whitney)
Catheter B: p = 0.0039, Wilcoxon (Mann-Whitney)

Population analysed: ITT

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Catheter A	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Catheter B	0 of 10 (0%)	3 of 10 (30%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bacteriuria

Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
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Not yet recruitingObservational study
Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
Pre-Eclampsia, Asymptomatic Bacteriuria
Not yet recruiting
Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Disease
RecruitingPhase 1
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
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RecruitingObservational study
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter

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.

Waigh El Masri, Mr principal investigator

The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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?

Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Bacteria Count Change From Baseline and After 24 Hours. (time frame: Baseline and after 24 hours). The study lists 3 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 NCT01143116.

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 3 May 2022.