Urinary Tract InfectionsNCT00318591
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
A study testing SpeediCath and Conveen Uncoated in people with Urinary Tract Infections, run by Coloplast A/S at 16 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- SpeediCath and Conveen Uncoated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Apr 2006to Oct 2009
- 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
- Traumatic spinal cord injury within 3 months prior to inclusion
- Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Who cannot join
- Has symptoms of UTI at inclusion
- Treated with prophylactic antibiotics to prevent UTIs
- Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract
- Has used intermittent catheterization for more than 10 days prior to inclusion
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States12 sites
University of Michigan Helaths Systems
Ann Arbor, Michigan, 48108
Shepherd Center
Atlanta, Georgia, 30309
Boston Medical School
Boston, Massachusetts, 02188
Carolinas Medical Center
Charlotte, North Carolina, 28303
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Craig Hospital
Englewood, Colorado, 80113
The Institute for Rehabilitation and Research (TIRR)
Houston, Texas, 77030
University of Miami
Miami, Florida, 33101
Mount Sinai School of Medicine
New York, New York, 10029
Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation
Rochester, Minnesota, 55902
Santa Clara Valley Medical Center
San Jose, California, 95128
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
Canada4 sites
University of Alberta
Edmonton, Alberta, T6G 2C8
Parkwood Rehabilitation Centre
London, Ontario, N6A 4G5
Toronto Rehabilitation Centre
Toronto, Ontario, M4G 3V9
G.F.Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: A Prospective, Randomized, Parallel-group, Multi-center Study to Compare the Occurrence of Urinary Tract Infections in Patients With Spinal Cord Injury Using Either Coated or Uncoated Intermittent Catheters.
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.
Read the detailed description
Introduction:
Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. However, IC several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (UTI).
Attempts to control UTI with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. The hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. Two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic UTI, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. Currently, while there are trends in favour of hydrophilic-coated catheters with respect to UTI overall evidence remains inadequate for clinical decision-making for choice of catheter type. Randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of UTI5. Conclusions of the Cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of UTI, but further robust research is required.
- Conditions
- Urinary Tract Infections
- Being tested
- SpeediCath, Conveen Uncoated
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeediCathDevice
Also called Coated Catheter
hydrophilic coated urinary intermittent catheter
Conveen UncoatedDevice
Also called Uncoated catheter
Uncoated urinary intermittent catheter
| Study group | Role | What they receive |
|---|---|---|
| SpeediCath | Experimental | hydrophilic-coated intermittent catheter Receives: Device: SpeediCath |
| Conveen Uncoated | Experimental | uncoated urinary intermittent catheter Receives: Device: Conveen Uncoated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Measured: 4-6 months
Secondary outcomes (6)
UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis
Measured: 4-6 months
Nurse Evaluation of Catheters - Overall Satisfaction
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Measured: 4-6 months
Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Measured: 4-6 months
Nurse Time Spent on Catheterization Procedure
Measured: 4-6 months
Device-related or Possibly Device-related AEs
Measured: 4-6 months
Number of Participants With One or More Urinary Tract Infection
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2009
- Study completionOct 2009
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 Urinary Tract InfectionsStudies 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
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Cardenas, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318591
- Sponsor's protocol ID
- DK046CC
- Status last verified
- Aug 2015
- First submitted
- 26 Apr 2006
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel-group, Multi-center Study to Compare the Occurrence of Urinary Tract Infections in Patients With Spinal Cord Injury Using Either Coated or Uncoated Intermittent Catheters.
- ClinicalTrials.gov ID
- NCT00318591
- Acronym / sponsor ID
- DK046CC
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 25 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder. Patients will use either a coated catheter or an uncoated catheter with gel.
Detailed description
Introduction:
Spinal cord injured (SCI) constitutes a large group of patients suffering from neurogenic bladder dysfunction, which is often managed by intermittent catheterization (IC). Intermittent catheterization is accepted as a safe and effective method for maintaining bladder and renal health in individuals with neurogenic bladder dysfunction. However, IC several times a day places an individual at risk for urethral trauma, hematuria, and particularly symptomatic urinary tract infections (UTI).
Attempts to control UTI with prophylactic antibiotics or sterile technique have not been overly successful but more recent advances in catheter technology, such as the hydrophilic-coated catheter, offer potential benefit. The hydrophilic-coated catheter has a slippery, pre-lubricated surface (along the entire length of the catheter) when soaked in water, allowing smooth insertion without the need for additional water soluble lubricant. Two proposed advantages over uncoated catheters are 1) reduced incidence of symptomatic UTI, and 2) reduction of urethral irritation or urethral trauma, and lowered risk of urethral strictures. Currently, while there are trends in favour of hydrophilic-coated catheters with respect to UTI overall evidence remains inadequate for clinical decision-making for choice of catheter type. Randomised trials to date have been limited by short follow up, heterogeneity, attrition, imprecise outcome measures, and varying definitions of UTI5. Conclusions of the Cochrane group in 20076 were echoed in a recent comprehensive re-view of all studies on hydrophilic-coated catheters - there is modest evidence favouring hydrophilic-coated catheter in reduction of UTI, but further robust research is required.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpeediCath | Experimental | Device: SpeediCathhydrophilic-coated intermittent catheter |
| Conveen Uncoated | Experimental | Device: Conveen Uncoateduncoated urinary intermittent catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Traumatic spinal cord injury within 3 months prior to inclusion
- Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Key exclusion criteria (4 listed)
- Has symptoms of UTI at inclusion
- Treated with prophylactic antibiotics to prevent UTIs
- Has a history of unresolved bladder-ureteral reflux and/or stones in the urinary tract
- Has used intermittent catheterization for more than 10 days prior to inclusion
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 |
|---|---|---|
| SpeediCathAlso: Coated Catheterhydrophilic coated urinary intermittent catheter | Device | SpeediCath |
| Conveen UncoatedAlso: Uncoated catheterUncoated urinary intermittent catheter | Device | Conveen Uncoated |
Primary outcome
Occurrence of Symptomatic Urinary Tract Infections (UTIs)
Time frame: 4-6 months
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
6 secondary outcomes
UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
Time frame: 4-6 months
Nurse Evaluation of Catheters - Overall Satisfaction
Time frame: 4-6 months
Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction
Time frame: 4-6 months
Nurse Time Spent on Catheterization Procedure
Time frame: 4-6 months
Device-related or Possibly Device-related AEs
Time frame: 4-6 months
Number of Participants With One or More Urinary Tract Infection
Time frame: 4-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Diana Cardenas, MD principal investigator
University of Miami
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpeediCath and Conveen Uncoated in people with Urinary Tract Infections, run by Coloplast A/S at 16 sites in 2 countries.
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 2 inclusion and 4 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. 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 25 May 2011). 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?
Occurrence of Symptomatic Urinary Tract Infections (UTIs) (time frame: 4-6 months). 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 10 Feb 2021.