SpeediCath
Devicehydrophilic coated urinary intermittent catheter
Other names: Coated Catheter
NCT Number: NCT00318591
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Alberta, Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
hydrophilic coated urinary intermittent catheter
Other names: Coated Catheter
Uncoated urinary intermittent catheter
Other names: Uncoated catheter
Time frame: 4-6 months
Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI
Time frame: 4-6 months
UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis
Time frame: 4-6 months
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Time frame: 4-6 months
Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Time frame: 4-6 months
Time frame: 4-6 months
Time frame: 4-6 months
Coloplast A/S
Industry
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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