Darouiche et al. 2005
USA
PEDro=8
RCT
N=27

Population: SCI of ≥1 year with ≥2 UTIs/year; Experimental group: Mean age = 52 yrs; Level of injury: paraplegia = 11, tetraplegia = 10; Control group: Mean age = 52 yrs; Level of injury: paraplegic = 2, tetraplegic = 4.
Treatment: Randomly assignment (3:1 ratio) and double-blinding to bladder inoculation with either E.coli 83972 vs sterile normal saline. 2 bladder instillations / day for 3 consecutive days.
Outcome Measures: Prevalence of UTI, risks of UTI. Urine samples were analyzed at 1 week after bladder inoculation then monthly for 1 year.

• 62% of patients with E coli and all of the patients with saline developed at least 1 episode of UTI during the 1 year follow-up (p=0.07).
• The number of UTI episodes that occurred were significantly lower (p=0.036) with E coli vs saline.
• Colonized patients were significantly less likely than non-colonized patients to develop at least 1 episode of UTI during the 1 year follow up (p=0.01).
• Kaplan-Meier estimates of risk of UTI showed bladder colonization was protective against infection (p=0.002).
• 62% of the experimental group became colonized with E.coli 83972 for > than 1 month and 4 patients remained colonized throughout the 12 months, while 9 lost the inoculation after an average of 3.5 months.

Hull et al. 2000
USA/Sweden
Downs & Black score=17
Pre-Post
N=21

Population: SCI with a history of symptomatic UTI in the past year: Age = 29-55 yrs; Gender: males = 18, females = 3; Severity of injury: AIS A = 10, B = 6, C = 3, D = 2; Time since injury: 5-24 months.
Treatment: Patients were treated with antibiotics for 5 to 7 days.  After 48 to 72 hours, patients were inoculated 3 times a day for 3 days with E.coli 83972. Protocol was repeated up to 3 times if patients did not show colonization. After 3 cycles no attempts were made to colonize.
Outcome Measures: Successful colonization, duration of colonization, self-reported UTI, treatment for UTI, quality of life reported at variable follow-up over ~1 year.

• No symptomatic UTIs were seen in subjects while colonized with E.coli 83972.
• Successful colonization was achieved in 13 of 21 patients.
• Mean duration of colonization was 12.3 months.
• UTIs seen in 4 patients not successfully colonized and in 5/7 who lost colonization over a mean 3.4 month follow-up.
• There was a significant correlation between elevated voiding pressure and likelihood of successful colonization (p=0.02).
• Mean quality of life of subjects who remained colonized increased from 1.8 before colonization to 4.6 after (out of 5).

Prasad et al. 2009
USA
D&B=18
Pre-Post
N=13

Population: Mean age=56yrs; Gender: males
Treatment: SCI patients with history of UTIs were given a catheter coated with E. Coli 83972 which was left in situ for three days, then removed and the patient was followed.
Outcome Measures: Colonization, UTIs, adverse events.

• Overall 62% of participants became colonized with the bacteria; only 42% were due to a single inoculation.
• Success rate of inoculation after preinsertion antibiotics was greater than that without preinsertion antibiotics (55% vs 33%); however, this did not reach significance.
• UTI rate for participants that became colonized decreased from 2.29 per subject year at baseline to 1.98 one year post insertion of catheters.(no significance given)
• Adverse events reported included fever, chills, groin pain, dysreflexia and hematuria.