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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

Schiotz 1996.

Study characteristics
Methods Study design: RCT
Dates study conducted: November 199‐April 1994
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
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
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)
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.
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
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