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A prospective randomized, parallel-group, multi-center study to compare the occurrence of urinary tract infections in patients with SCI using either coated or uncoated intermittent catheters

PI: Amit Jha, MD, MPH
Funded by: Coloplast A/S
Dates: 2005-2008
Contact: Amy Dannels McClure – adannels-McClure@craighospital.org 303 789 8562

Most individuals with SCI have some degree of bladder dysfunction. For some of our patients an intermittent catheterization programs (ICP), is the best option for management of their neurogenic bladder. However, the insertion of a catheter into the bladder several times a day may give rise to complications such as urethral strictures, bleeding and most importantly urinary tract infections (UTIs). UTIs represent a large percentage of secondary complications experienced by individuals following a SCI.

Data suggests that compared to uncoated intermittent catheters, hydrophilic-coated intermittent catheters are associated with decreased urethral irritation and may lead to a decrease in both bacteriuria and long-term urethral complications including urinary tract infections (UTI). The purpose of this open-label, prospective, randomized, parallel-group, multi-center study is to investigate the occurrence of symptomatic UTIs in adult SCI individuals during their initial rehabilitation and for up to 3 months following discharge from the hospital.

Eligible participants are enrolled in the study during their initial rehabilitation at Craig Hospital. They will be randomized to a catheterization program using either a coated intermittent catheter (SpeediCath) or an uncoated intermittent catheter (Conveen).

This study involves 16 different hospitals across the United States and Canada. The primary objective is to determine if the group using the coated catheters experience less symptomatic UTIs. Other objectives for the study include:

• Participant (or caregiver) and nurse satisfaction with the catheter
• Time spent on the catheterization process
• Health economic measures
• Adverse events
• Bacteriuria, urine leukocytes and erythrocytes