Colonizing Neurogenic Bladders With Benign Flora
Colonizing Neurogenic Bladders With Benign Flora
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.
The unifying goal of our work is to develop new approaches for the prevention of urinary
 tract infection (UTI) in persons with spinal cord injury (SCI). Most individuals with SCI
 have neurogenic bladders, and the resulting urinary stasis and bladder catheterization
 predispose them to recurrent UTI. Currently few, if any, measures are effective at prevention
 of UTI in persons with neurogenic bladders.

 Bacterial interference, or using benign bacteria to prevent infection with virulent
 pathogens, may offer a solution to the significant problem of recurrent episodes of UTI in
 persons with SCI. Two trials in persons with SCI of instilling nonpathogenic Escherichia coli
 (83972) directly into the bladder demonstrated a strong association between colonization with
 this non-pathogen and decreased frequency of UTI. However, the successful colonization rate
 of the direct inoculation method was low (51-62%). Since a urinary catheter-associated
 biofilm, or bacteria plus extracellular matrix, continually seeds the bladder with bacteria,
 we proposed to use urinary catheters that had been pre-coated with a biofilm of E. coli 83972
 as a means to achieve bladder colonization. Our recently completed pilot (B3248P)
 demonstrated that insertion of urinary catheters pre-coated with E. coli (83972) was an
 effective and safe method to achieve bladder colonization with this potentially protective
 strain. The rate of successful colonization with the E. coli-coated catheters was high (10 of
 12 subjects, or 83%). However, this pilot was limited to the subpopulation of SCI veterans
 who utilize chronic indwelling catheters for bladder drainage.

 The current proposal expands upon previous work by widening the range of eligible subjects
 and by simplifying the colonization protocol. Since an intermittent catheterization program
 (ICP) is a preferred and more common means of managing neurogenic bladders than chronic
 catheterization, we now plan to test E. coli 83972-coated catheters in persons with SCI who
 use ICP for bladder drainage. We hypothesize that short-term use (3 days) of E. coli
 83972-coated catheters in persons with SCI practicing ICP will lead to successful
 colonization (persisting 28 days or more) in the majority of subjects. We will also record
 subjects' rates of symptomatic UTI while colonized with E. coli 83972 and compare these rates
 to the subjects' baseline rates in the year prior to study entry. Subjects will be able to
 remove their study catheters at home and to submit urine samples by mail, so the colonization
 process will simple and convenient. If successful colonization is achieved in this pilot
 trial, a larger clinical trial will be designed to test the efficacy of these catheters at
 preventing UTI in persons with SCI.
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.