Schiotz 1996.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: November 199‐April 1994 |
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Participants |
Number of participants: eligible, not reported; 109 randomised; 91 reported Country: Norway Population: women Age (mean and range): overall 50.3 (26.9‐72.6) Inclusion criteria: women admitted for elective retropubic surgery for urinary stress continence Condition for hospitalisation: elective retropubic surgery for urinary stress incontinence Exclusion criteria: not reported Use of antibiotic prophylaxis: not reported |
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Interventions |
Group A (n = 45): IUC removal after 1 day Group B (n = 46): IUC removal after 3 days Size and type of catheter used: 12 or 14 Fr Foley catheter, Teflon‐coated Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: 1 day post‐op IUC B: 3 day post‐op IUC |
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Outcomes | UTI Delayed spontaneous voiding after catheter removal Recatheterisation Length of hospital stay Asymptomtic bacteriuria (cannot be incorporated as reported as total number without the numbers in each group) |
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Definition of CAUTI or bacteriuria | Cultures were defined as positive when an midstream urine specimen yielded > 100,000 cfu/mL of any organism, or a catheter specimen yielded > 10,000 cfu/mL. UTI was defined as a positive culture associated with dysuria, pain, fever or sepsis. Asymptomatic bacteriuria was defined as a positive culture in the absence of symptoms. If there was doubt, participants were defined as having UTI rather than asymptomatic bacteriuria. |
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Sponsorship/funding | This study was supported by a grant from Anders Jahre’s Foundation, Oslo, Norway. | |
Ethical approval | Not reported | |
Notes | 18 participants were excluded following randomisation; 15 participants were excluded as they were administered antibiotic prophylaxis and 3 had confounding post‐op antibiotic treatment Cultures were defined as positive when a midstream urine specimen yielded > 100,000 cfu/mL of any organism or a catheter specimen yielded > 10,000 cfu/mL UTI was defined as a positive culture associated with dysuria, pain, fever or sepsis Asymptomatic bacteriuria was defined as positive culture in the absence of symptoms |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Patients were pre‐operatively randomized to …” Comment: randomisation method unclear |
Allocation concealment (selection bias) | Low risk | Quote: “… by means of a nurse drawing a closed envelope.” Comment: envelopes were concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely that blinding of participants occurred |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Urine cultures were taken from microscopy and culture. Suggests that microbiologist processed them at a laboratory and so unlikely to know which patients were part of the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “15 patients were excluded owing to …” Comment: reasons for withdrawals given. Participants who completed the study are reported in full |
Selective reporting (reporting bias) | Low risk | All outcomes reported in full. However, protocol not available for assessment |
Other bias | Low risk | Appears to be free from other sources of bias |