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.

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

Urinary Tract Infections

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.

SpeediCath

Conveen Uncoated

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.

Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI

UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis

Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)

Rancho Los Amigos National Rehabilitation Center

Santa Clara Valley Medical Center

Craig Hospital

University of Miami

Shepherd Center

Boston Medical School

University of Michigan Helaths Systems

Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation

Kessler Institute for Rehabilitation

Mount Sinai School of Medicine

Carolinas Medical Center

The Institute for Rehabilitation and Research (TIRR)

University of Alberta

G.F.Strong Rehabilitation Centre

Parkwood Rehabilitation Centre

Toronto Rehabilitation Centre

Total

Age, Continuous

Female

Male

Sex/Gender, Customized

United States

Canada

Region of Enrollment

Anna Karina Busch, Intl. Senior Scientific Manager

The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.

Free of UTIs from study start to day 30

Free of UTIs from study start to day 150

SpeediCath Catheter

ITT-population, symptomatic urinary tract infections treated with antibiotics

Occurrence of Symptomatic Urinary Tract Infections (UTIs)

UTIs with bacteriuria \>=100 Colony Forming Units (CFU)/ml. Descriptive analysis

UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml

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)

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?