McDonald 1999.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: November 1995‐October 1996 |
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Participants |
Number of participants: eligible, unclear; 48 randomised; 48 reported Country: Australia Population: men Inclusion criteria: patients undergoing TURP Condition for hospitalisation: TURP Exclusion criteria: not reported Age (mean and range): A 66.7 (51‐81); B 68.7 (57‐89); overall: 67.8 (51‐89) Use of antibiotic prophylaxis: not reported |
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Interventions |
Group A (n = 20): removal of IUC at midnight Group B (n = 28): removal of IUC at 6 am Size and type of catheter used: not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC removed at midnight B: IUC removed at 6 am |
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Outcomes | Mean volume of first void Mean time to first void Discharged same day as IUC removal Discharged next day |
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Definition of CAUTI or bacteriuria | Not reported | |
Sponsorship/funding | Not reported | |
Ethical approval | “The study was approved by the research committee; verbal consent was judged adequate for participation in this investigation.” | |
Notes | 3 participants were withdrawn from analysis as 1 passed urine in the toilet without informing the staff, the second experienced an extended length of stay due to superficial vein thrombosis and the third failed his trial of void for 10 h after catheter removal. There was no significant difference between the 2 groups with respect to tissue pathology. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “A random‐digit chart was used to allocate patients” Comment: method of randomisation unclear |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely participants were able to be blinded. |
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 | Unclear risk | 3/48 excluded from analysis. Unclear which group these 3 belonged to. |
Selective reporting (reporting bias) | Low risk | All outcomes seem to be reported in full in both the methods and results section. Protocol not available. |
Other bias | Low risk | Appears to be free from other sources of bias |