N/A
N=219
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT00318591 ↗Enrolled (actual)
219
Serious AEs
5.0%
Results posted
May 2011
Primary outcome: Primary: Occurrence of Symptomatic Urinary Tract Infections (UTIs) — 19; 20; 2; 0 participants — p=0.0383
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SpeediCath (Device); Conveen Uncoated (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Symptomatic Urinary Tract Infections (UTIs) |
19; 20; 2; 0 | 0.0383 sig |
| SECONDARY UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml |
101; 151 | — |
| SECONDARY Nurse Evaluation of Catheters - Overall Satisfaction |
8.1; 8.3 | 0.7670 |
| SECONDARY Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction |
9.3; 8.6 | 0.0074 sig |
| SECONDARY Nurse Time Spent on Catheterization Procedure |
337; 278 | — |
| SECONDARY Device-related or Possibly Device-related AEs |
16; 14 | — |
| SECONDARY Number of Participants With One or More Urinary Tract Infection |
47; 82 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Traumatic spinal cord injury within 3 months prior to inclusion
- Neurogenic bladder dysfunction requiring intermittent catheterization at least 3 times daily
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00318591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.