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Completed

NCT Number: NCT00318591

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpeediCath

Device

hydrophilic coated urinary intermittent catheter

Other names: Coated Catheter

Conveen Uncoated

Device

Uncoated urinary intermittent catheter

Other names: Uncoated catheter

Primary outcomes

  1. Occurrence of Symptomatic Urinary Tract Infections (UTIs)

    Time frame: 4-6 months

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

Secondary outcomes

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

    Time frame: 4-6 months

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

  2. Nurse Evaluation of Catheters - Overall Satisfaction

    Time frame: 4-6 months

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

  3. Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction

    Time frame: 4-6 months

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

  4. Nurse Time Spent on Catheterization Procedure

    Time frame: 4-6 months

  5. Device-related or Possibly Device-related AEs

    Time frame: 4-6 months

  6. Number of Participants With One or More Urinary Tract Infection

    Time frame: 4-6 months

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2006
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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