|Darouiche et al. 2011|
|Population: Male SCI: Mean age: 52 yr (range 29-85 yr); Injury level: Tetraplegia =14, paraplegia=12; Bladder management type: Indwelling transurethral catheter=7, indwelling suprapubic catheter=6, intermittent catheterization=13, external condom=1.|
Intervention: Individuals were randomly allocated to either bacterial interference (E.coli HU2117) (n=17) or a placebo (n=10) for prevention of urinary tract infections (UTI).
Outcome Measures: Number of UTI episodes.
|1. 5/17 (29%) of the experimental group and 7/10 (70%) of the control group developed >1 UTI during the 1-yr follow-up (p=0.049).|
2. The average number of episodes of UTI/individual per yr was also lower and significantly different in the experimental versus control groups (p=0.02).
|Darouiche et al. 2005|
|Population: SCI of ≥1 yr with ≥2 UTIs/yr; Experimental group: Mean age: 52 yr; Level of injury: paraplegia=11, tetraplegia=10; Control group: Mean age: 52 yr; Level of injury: paraplegic=2, tetraplegic=4.|
Intervention: Randomly assignment (3:1 ratio) and double-blinding to bladder inoculation with either E.coli 83972 versus sterile normal saline. 2 bladder instillations/d for 3 consecutive d.
Outcome Measures: Prevalence of urinary tract infections (UTI), risks of UTI. Urine samples were analyzed at 1 wk after bladder inoculation then monthly for 1 yr.
|1. 13 individuals with E coli and all of the individuals with saline developed at least 1 episode of UTI during the 1 yr follow-up (p=0.07).|
2. The number of UTI episodes that occurred were significantly lower (p=0.036) with E coli versus saline.
3. Colonized individuals were significantly less likely than non-colonized individuals to develop at least 1 episode of UTI during the 1 yr follow up (p=0.01).
4. Kaplan-Meier estimates of risk of UTI showed bladder colonization was protective against infection (p=0.002).
5. 13 individuals of the experimental group became colonized with E.coli 83972 for>1 mo and 4 individuals remained colonized throughout the 12 mo, while 9 lost the inoculation after an average of 3.5 mo.
|Trautner et al. 2007|
|Population: Adult SCI individuals, who had a SCI>1 yr, whom required an indwelling catheter for drainage and had at least 1 clinically recognized urinary tract infection (UTI) in the past.|
Intervention: Insertion of a urinary catheter incubated with E.coli HU2117.
Outcome Measures: Colony success (absence of proteus (uropathogen) and duration of catheter insertion).
|1. No individual experienced UTI symptoms attributable to colonization with E.coliHU2117.|
2. Proteus absence was significantly related to a longer duration of E.coliHU2117 colonization (p=0.04).
3. Catheters left in place for longer periods of time resulted in a longer duration of colonization (p=0.002).
|Hull et al. 2000|
|Population: SCI with a history of symptomatic UTI in the past year: Mean age: 29-55 yr; Gender: males=18, females=3; Severity of injury: AIS A=10, B=6, C=3, D=2; Time post-injury: 5-24 mo.|
Intervention: Individuals were treated with antibiotics for 5 to 7 d. After 48 to 72 h, individuals were inoculated 3 times a d for 3 d with E.coli 83972. Protocol was repeated up to 3 times if individuals did not show colonization. After 3 cycles no attempts were made to colonize.
Outcome Measures: Successful colonization, duration of colonization, self-reported urinary tract infection (UTI), treatment for UTI, quality of life (QoL) reported at variable follow-up over ~1 yr.
|1. No symptomatic UTIs were seen in subjects while colonized with E.coli 83972.|
2. Successful colonization was achieved in 13 of 21 individuals.
3. Mean duration of colonization was 12.3 mo.
4. UTIs seen in 4 individuals not successfully colonized and in 5/7 who lost colonization over a mean 3.4 mo follow-up.
5. There was a significant correlation between elevated voiding pressure and likelihood of successful colonization (p=0.02).
6. Mean QoL of subjects who remained colonized increased from 1.8 before colonization to 4.6 after (out of 5).
|Prasad et al. 2009|
|Population: Mean age: 56 yr; Gender: males=13, females=0.|
Intervention: SCI individuals with history of urinary tract infections (UTIs) were given a catheter coated with E. Coli 83972 which was left in situ for three d, then removed and the individual was followed.
Outcome Measures: Colonization, UTIs, adverse events.
|1. Overall 8 participants became colonized with the bacteria; only 3 were due to a single inoculation.|
2. Success rate of inoculation after preinsertion antibiotics was greater than that without preinsertion antibiotics (55% versus 33%); however, this did not reach significance.
3. UTI rate for participants that became colonized decreased from 2.29 per at baseline to 1.98 one yr post insertion of catheters. (no significance given)
4. Adverse events reported included fever, chills, groin pain, dysreflexia and hematuria.