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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpeediCath | Experimental | hydrophilic-coated intermittent catheter |
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| Conveen Uncoated | Experimental | uncoated urinary intermittent catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath | Device | hydrophilic coated urinary intermittent catheter |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI | 4-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml | UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis | 4-6 months |
| Nurse Evaluation of Catheters - Overall Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Cardenas, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center | Downey | California | 90242 | United States | ||
| Santa Clara Valley Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | SpeediCath | Hydrophilic coated intermittent catheter |
| FG001 | Conveen Uncoated | Uncoated intermittent catheter |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Conveen Uncoated | Device | Uncoated urinary intermittent catheter |
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Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
| 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) | 4-6 months |
| Nurse Time Spent on Catheterization Procedure | 4-6 months |
| Device-related or Possibly Device-related AEs | 4-6 months |
| Number of Participants With One or More Urinary Tract Infection | 4-6 months |
| San Jose |
| California |
| 95128 |
| United States |
| Craig Hospital | Englewood | Colorado | 80113 | United States |
| University of Miami | Miami | Florida | 33101 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Boston Medical School | Boston | Massachusetts | 02188 | United States |
| University of Michigan Helaths Systems | Ann Arbor | Michigan | 48108 | United States |
| Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation | Rochester | Minnesota | 55902 | United States |
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28303 | United States |
| The Institute for Rehabilitation and Research (TIRR) | Houston | Texas | 77030 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| G.F.Strong Rehabilitation Centre | Vancouver | British Columbia | V5Z 2G9 | Canada |
| Parkwood Rehabilitation Centre | London | Ontario | N6A 4G5 | Canada |
| Toronto Rehabilitation Centre | Toronto | Ontario | M4G 3V9 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SpeediCath | Hydrophilic coated intermittent catheter |
| BG001 | Conveen Uncoated | Uncoated intermittent catheter |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Gender is unknown for one participant | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Symptomatic Urinary Tract Infections (UTIs) | Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI | ITT-population, symptomatic urinary tract infections treated with antibiotics | Posted | Number | participants | 4-6 months |
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| Secondary | UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml | UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis | Descriptive only | Posted | Number | UTI | 4-6 months |
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| Secondary | Nurse Evaluation of Catheters - Overall Satisfaction | Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction) | Analysis were done on evaluations of the ITT-population. Evaluations were made at discharge from hospital. Since some participants discontinued the study prior to discharge and since some did not fill in the evaluation form, the total number of evaluations (132) do not add up to the total of the ITT population (219) | Posted | Mean | Standard Deviation | scores on a scale | 4-6 months |
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| Secondary | Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction | Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction) | ITT population | Posted | Mean | Standard Deviation | scores on a scale | 4-6 months |
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| Secondary | Nurse Time Spent on Catheterization Procedure | ITT-population | Posted | Mean | Standard Deviation | seconds | 4-6 months |
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| Secondary | Device-related or Possibly Device-related AEs | Posted | Number | Events | 4-6 months |
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| Secondary | Number of Participants With One or More Urinary Tract Infection | Posted | Number | participants | 4-6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SpeediCath | Hydrophilic coated intermittent catheter | 5 | 105 | 16 | 105 | ||
| EG001 | Conveen Uncoated | Uncoated intermittent catheter | 6 | 114 | 14 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| subdural hematoma | General disorders | Non-systematic Assessment | not device-related |
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| deep vein thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| urosepsis | Renal and urinary disorders | Non-systematic Assessment |
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| perforated bladder/cystitis/decreased oxygen saturation | Renal and urinary disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment |
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| reproductive system and breast disorders | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Karina Busch, Intl. Senior Scientific Manager | Coloplast | +45 49112350 | dkakb@coloplast.com |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Male |
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| Canada |
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The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.
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