Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Device: Conveen Uncoated; Device: SpeediCath

• Registration Number: NCT00318591
• Lead Sponsor: Coloplast A/S

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2011-02-23
• Results First Submitted QC: 2011-04-26
• Results First Posted: 2011-05-25
• Status Verified: 2015-08
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conveen Uncoated	Conveen Uncoated	uncoated urinary intermittent catheter
SpeediCath	SpeediCath	hydrophilic-coated intermittent catheter

Primary Outcome Measures

Name	Time	Method
Occurrence of Symptomatic Urinary Tract Infections (UTIs)	4-6 months	Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI

Secondary Outcome Measures

Name	Time	Method
UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml	4-6 months	UTIs with bacteriuria \>=100 Colony Forming Units (CFU)/ml. Descriptive analysis
Nurse Evaluation of Catheters - Overall Satisfaction	4-6 months	Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)
Device-related or Possibly Device-related AEs	4-6 months
Nurse Time Spent on Catheterization Procedure	4-6 months
Number of Participants With One or More Urinary Tract Infection	4-6 months
Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction	4-6 months	Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)

Trial Locations

Locations (16)

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States

Craig Hospital; 🇺🇸 Englewood, Colorado, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Boston Medical School; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Helaths Systems; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic, Saint Mary Hospital MB3CF Rehabilitation; 🇺🇸 Rochester, Minnesota, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

G.F.Strong Rehabilitation Centre; 🇨🇦 Vancouver, British Columbia, Canada

Parkwood Rehabilitation Centre; 🇨🇦 London, Ontario, Canada

Toronto Rehabilitation Centre; 🇨🇦 Toronto, Ontario, Canada

Kessler Institute for Rehabilitation; 🇺🇸 West Orange, New Jersey, United States

The Institute for Rehabilitation and Research (TIRR); 🇺🇸 Houston, Texas, United States