Phase 1 N=13 Prevention

Colonizing Neurogenic Bladders With Benign Flora

Spinal Cord Injury · Urinary Tract Infection

Bottom Line

View on ClinicalTrials.gov: NCT00371631 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Bladder Colonization — 62 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Insertion of urinary catheters coated with E. coli 83972 (Biological)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Bladder Colonization	62	—
SECONDARY The Rate of Symptomatic UTI While Colonized	2.27; 1.98	—

Summary

The purpose of the research is to determine whether we can get harmless bacteria to live in the bladders of persons with spinal cord injury who practice intermittent bladder catheterization. We will also look at whether having the harmless bacteria in the bladder prevents urinary tract infections from occurring.

Eligibility Criteria

Inclusion Criteria

Patients followed at the MEDVAMC who have sustained spinal cord injury > 12 months earlier, suffer from neurogenic bladder, practice intermittent bladder catheterization, and who have had at least 1 symptomatic UTI in the past will be enrolled.

Exclusion Criteria

Exclusion criteria will include obstructive urolithiasis, indwelling bladder or nephrostomy catheters, supravesical urinary diversion, vesicoureteral reflux, active malignancy, uncontrolled diabetes mellitus, AIDS, requirement for immunosuppressive medication, or current antibiotic therapy. Women of childbearing age must have a negative pregnancy test before enrolling in the study, and they must utilize effective birth control methods during the study and for 3 months after the study is concluded.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00371631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.