| Methods |
Study design: parallel, placebo‐controlled, double‐blind RCT Study duration: not reported Duration of follow‐up: 1 year |
| Participants |
Country: USA Setting: outpatient, multicenter (6) Adults with spinal cord injuries for ≥ 1 year, neuropathic bladders requiring catheterization (indwelling or intermittent catheters) or external collection device, ≥ to 2 symptomatic UTI in preceding year Number (randomised/analysed): treatment group (45/17); control group (14/10) Mean age, range (years): treatment group (48, 29 to 78); control group (56, 30 to 85) Sex: all males Comorbidities: not reported Exclusion criteria: obstructing urolithiasis; history of autonomic dysreflexia within previous 3 months; supravesical urinary diversion; VUR; bladder volume < 50 mL; nephrostomy tube; vascular or urologic implants; infection‐prone congenital or acquired cardiac disease; uncontrolled DM; immunocompromised, extra‐urogenital infections requiring prolonged antibiotics; pregnant and fertile women engaging in unprotected intercourse; inability to provide inform consent; persons judged unreliable in maintaining follow‐up; children |
| Interventions |
Treatment group
Control group
|
| Outcomes |
|
| Notes |
27 patients that they analysed were males. Authors did report that they enrolled 5 female patients in the initial 45 patients but none of the females had successful inoculation Results reported were not intention to treat, more drop outs in the treatment than placebo group Analysis was only conducted on patients who had the 1 year follow‐up Kaplan‐Meier survival curves showed better survival to UTI in patients with successful bladder colonisation of E. coli HU2117 than those on placebo (P = 0.04) Authors also reported average number of episodes of UTI/patient‐year was lower in the treatment group (0.50) versus control group (1.68) (P = 0.02) Funding: National Institute of Health |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Clearly stated randomisation was computer generated for each centre |
| Allocation concealment (selection bias) |
Low risk |
Stated that placebo inoculum visually identical to bacterial inoculum |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Clearly stated patients and investigators were blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Clearly stated outcome assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Clinical characteristics of the 27 patients who were followed up till 1 year was similar. However, no characteristics of the 32 patients who had initial bladder inoculation but dropped out was mentioned. There were more drop outs in the treatment than placebo group 28 versus 4. Authors did mention that patient compliance with inoculation protocol was low to account for the reason that losses to follow‐up was higher in the treatment group
Although 59 patients received bladder inoculation, only 27 patients were evaluated and analysed up to the 1 year follow‐up period. The survival analysis were only based on patients who completed the one year follow‐up period and did not account for the loss to follow‐ups; high risk of bias as not fully intention to treat |
| Selective reporting (reporting bias) |
High risk |
No reporting of adverse events except that female gender was associated with bladder colonisation failure |
| Other bias |
Low risk |
Study appears free of other biases |
