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Author Year
Country
Score
Research Design
Total Sample Size
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Methods
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Outcome
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Darouiche et al. 1994
USA
PEDro=9
RCT
N=40
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Population: SCI Inpatients: Treatment group: Mean age = 52.9 yrs; Gender: males = 18; Placebo group: Mean age = 46.9 yrs; Gender: males = 22.
Treatment: Double blind comparison of500mg of ciprofloxacin bid vs placebo bid for 3 days prior to urodynamic testing.
Outcome Measures: Incidence of UTI (culture), bacteriuria, pyuria, adverse events collected prior and 3-5 days post urodynamic testing.
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- 14% of patients in the placebo group and 0% of the patients in the treatment group developed symptomatic UTI but this was not significant (p=0.24).
- No adverse effects were reported.
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Gribble & Puterman 1993
Canada
PEDro=8
RCT
N=129
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Population: Acute (<30 days) SCI: Mean age = 38 yrs; Gender: males = 112, females = 17.
Treatment: Efficacy of trimethoprim-sulfamethoxazole (TMP-SMX id; TMP 40 mg, SMX 200 mg ) for UTI prophylaxis in acute SCI, during the first 4 mos of intermittent catheterization (IC). Breakthrough bacteriuria treated with conventional antimicrobial therapy and prophylaxis was continued.
Outcome Measures: Clinical: wkly rectal and urethral swab, and urine cultures collected for 4 months or until hospital discharge.
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- TMP-SMX more efficacious than placebo (P) prophylaxis:
- Lower incidence/freq/relapse of bacteriuria and symptomatic UTI in males (p<0.003 /0.0001/0.0001 and 0.0003).
- Similar trends in women.
- Other results:
- Adv. events similar btwn grps
- ≥1 TMP-SMX-resistant bacteriuria in all P subj. by yr 3.
- Rectal/urethral swab TMP-SMX-resistant organisms-both grps.
- TMP-SMX UTI prophylaxis effective in acute SCI/IC but emergent TMP-SMX-resistance limits usefulness.
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Biering-Sorensen et al. 1994
Denmark
PEDro=8
RCT
N=21
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Population: SCI with neurogenic bladder: Mean age = 38 yrs; Gender: males = 18, females = 3.
Treatment: Cross-over comparison of 6 months ciprofloxacin (100mg/night) vs placebo prophylaxis.
Outcome Measures: # UTI, urine and fecal cultures, side effects collected over 6 month periods.
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- Ciprofloxacin vs placebo prophylaxis (6mos): # UTIs greatly reduced with 5 vs 59 (p<0.00005)
- 1 instance of ciprofloxacin resistant E. coli found in the feces of 1 cipro patient
- No severe side effects.
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Sandock et al. 1995
USA
Downs & Black score=23
Prospective controlled trial
N=43
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Population: SCI inpatients; Treatment group: Mean age = 46 yrs; Gender: males = 20; Level of injury: lumbar = 2, paraplegic = 5, tetraplegia = 13; Mean time since injury = 9.2 yrs; Control group: Mean age = 58.3 yrs; Gender: males = 23; Level of injury: lumbar = 3, paraplegic = 8, tetraplegic = 12; Mean time since injury = 14.9 yrs.
Treatment: Comparison of 400mg trimethoprim-sulfamethoxazole (TMP-SMX) daily vs no treatment over a minimum of 3 months.
Outcome Measures: Incidence of asymptomatic bacteria, prevalence of UTI, types of bacteria present. Urine cultures weekly.
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- No significant difference was found between the control and treatment groups in:
- Incidence of asymptomatic bateriuria.
- Percent of cultures with asymptomatic bacteriuria (p>0.1).
- Incidence of symtomatic UTIs per week (p>0.5).
- Percentage of TMP-SMX resistant UTIs (p>0.5).
- Types of bacteria present.
- The control group was signficantly lower than the treatment group in:
- Percent of cultures with TMP-SMX resistant asymptomatic bateriuria (p<0.05).
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Salomon et al. 2006 France
Downs & Black score=12
Pre-post
N=38
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Population: SCI with neurogenic bladder and undergoing intermittent catheterization; Mean age = 45.9 yrs; Gender: males = 22, females = 16; Daily catheterizations = 6.
Treatment: Weekly oral cyclic antibiotic (WOCA): Wk 1-one antibiotic + wk 2 another antibiotic (over 2 yrs). Antibiotic choice based on urine culture results: amoxicillin 3000mg; trimethoprim/ sulfamethoxazole 320-1600mg; fosfomycin trometamol 6000mg; nitrofurantoin 300mg; cefixime 40mg.
Outcome Measures: Number of UTI's with weekly cultures for first 3 months and monthly thereafter over 2 years.
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- Before/after WOCA programme:
- Reduced symptomatic UTIs/ pt/yr from 9.4 to 1.8, p<0.01
- Reduced febrile UTI/pt/yr from 0.75 to 0.31, p<0.04
- Reduced hospitalization days from 4 to 1.2 days/patient, p<0.01.
- Decreased antibiotic consumption correlated with decreased incidence of UTIs over the course of the study.
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Reid et al. 1994b
Canada
Downs & Black score=11
Prospective controlled trial
N=14
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Population: SCI inpatients with intermittent catheterization: Age = 20-66 yrs; Gender: males = 11, females = 3.
Treatment: Comparison of co-trimoxazole (TMP-SMX 160/800 mg bid) vs no prophylaxis. Symptomatic UTIs were treated with appropriate antibiotic and a separate analysis was done on effect of fluoroquinolones (ciprofloxacin, ofloxacin and norfloxacin) on bladder biofilm bacteria.
Outcome Measures: Infection rate, extent of biofilm formation, level of bacterial adhesion; urine samples collected for culture and sonication for 8 wks.
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- TMP-SMX vs non-prophylaxis prophylaxis subjects:
- 54% vs 68% infection rate (not significant; no p value reported)
- E coli replaced by E faecalis as dominant uropathogen with TMPSMX use.
- 39±42 vs 44±49adherent bacteria/bladder cell (not significant; no p value reported)
- Laboratory results for treatment effect of fluoroquinolones vs TMP-SMX prophylaxis on biofilms:
- Reduced adhesion counts in favour of Fluoroquinolone vs TMP-SMX (63% vs 44%, no p value).
- 92%, 71%, 56% biofilm reduction with ciprofloxacin, ofloxacin & norfloxacin.
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