Bacteriuria, Intermittent CatheterizationNCT01782404
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
A study testing Chlorhexidine in people with Bacteriuria, Intermittent Catheterization, run by Wellspect HealthCare at 4 sites in Sweden.
Trial summary
This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteriuria, Intermittent Catheterization
- What is being tested?
- Chlorhexidine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesSweden
- Study dates
- Jan 2013to Jun 2014
- 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
- Provision of informed consent
- Female or male spinal cord injured subject aged 18 years and over
- Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit
- Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
- Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator
Who cannot join
- Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
- Ongoing antibiotic treatment
- Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
- Subject with severe catheterisation difficulties, as judged by investigator
- Known hypersensitivity to chlorhexidine
- Use of other instillation products
Show all 12Show fewer
- Pregnancy
- Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate)
- Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- Previous enrolment or allocation of treatment in the present study.
- Simultaneous participation in another clinical study that may interfere with the present study.
- Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Spinal Cord Injury Unit, Sahlgrenska University Hospital
Gothenburg, 413 45
Spinal Cord Injury Unit, Skåne University Hospital
Höör
Spinal Cord Injury Unit, Linköping University Hospital
Linköping
Neurocentrum, Neurorehab, Norrlands Universitetssjukhus
Umeå, 90185
About this study
This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.
The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).
- Being tested
- Chlorhexidine
- Medical subject headings
- Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDevice
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | Not described Receives: Device: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with bacteriuria <10^3 CFU/ml
Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample <10^3 CFU/ml within the 7 day treatment period will be evaluated.
Measured: 7 days
Secondary outcomes (1)
Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)
Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The number of days until reduction of bacteriuria (<10^3 CFU/ml) will be evaluated. Maximum treatment period is 7 days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteriuria, Intermittent CatheterizationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lena Rutberg, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782404
- Sponsor's protocol ID
- ABC-0008
- Status last verified
- Aug 2015
- First submitted
- 30 Jan 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
- ClinicalTrials.gov ID
- NCT01782404
- Acronym / sponsor ID
- ABC-0008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Feb 2013 (estimated)
- 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 a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.
The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (IC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Device: Chlorhexidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent
- Female or male spinal cord injured subject aged 18 years and over
- Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit
- Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month)
- Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator
Key exclusion criteria (12 listed)
- Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator.
- Ongoing antibiotic treatment
- Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator
- Subject with severe catheterisation difficulties, as judged by investigator
- Known hypersensitivity to chlorhexidine
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 |
|---|---|---|
| ChlorhexidineBladder irrigation with chlorhexidine 0.2 mg/ml twice daily | Device | Chlorhexidine |
Primary outcome
Proportion of patients with bacteriuria <10^3 CFU/ml
Time frame: 7 days
Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample <10^3 CFU/ml within the 7 day treatment period will be evaluated.
1 secondary outcome
Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)
Time frame: 7 days
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 13 Aug 2015.
Related trials for Bacteriuria, Intermittent Catheterization
RecruitingPhase 1
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Bacteriuria, Spinal Cord Injuries
Not yet recruiting
Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections.
Urinary Tract Disease
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.
Lena Rutberg, MD principal investigator
Sahlgrenska University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine in people with Bacteriuria, Intermittent Catheterization, run by Wellspect HealthCare at 4 sites in Sweden.
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 5 inclusion and 12 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
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?
Proportion of patients with bacteriuria <10^3 CFU/ml (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2015.