Souto 2004.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: January 2000‐July 2002 |
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| Participants |
Number of participants: eligible, not reported; 73 randomised; 73 reported Country: Brazil Population: men Age (mean ± SD (range)): overall: 62 (50‐73); A 64 ± 7.3 (50‐77); B 61 ± 7.3 (49‐73) Inclusion criteria: no cystography evaluation performed Condition for hospitalisation: retropubic radical prostatectomy Exclusion criteria: not reported Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 37): IUC removed 7 days after surgery Group B (n = 36): IUC removed 14 days after surgery Size and type of catheter used (e.g. Foley 16F): 2‐way 20Fr Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC removal 7 days post‐op B: IUC removal 14 days post‐op |
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| Outcomes | Urinary retention and haematuria Vesical neck stenosis Urinary incontinence Operating time |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | “… approved by the Institutional ethics committee” | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “The patients were randomized into 2 groups …” Comment: method of randomisation is unclear |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely blinding was possible. No other types of blinding reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | No microbiological outcomes reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the trial. No dropouts/withdrawals |
| Selective reporting (reporting bias) | Low risk | All outcomes in methods and results reported in full. However, protocol was not available for assessment |
| Other bias | Low risk | Appears to be free from other sources of bias |