Schiotz 1995.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: November 1992‐April 1994 |
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Participants |
Number of participants: eligible, not reported; 165 randomised; 165 reported Country: Norway Population: women Age (mean and range): overall 65.9 (29.9‐85.2) Inclusion criteria: not reported Condition for hospitalisation: elective vaginal plastic repair surgery (anterior colporrhaphy, anterior plus posterior colporrhaphy or a full Manchester repair) Exclusion criteria: not reported Use of antibiotic prophylaxis: not reported |
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Interventions |
Group A (n = 82): 1 day IUC post‐op Group B (n = 83): 3 days’ post‐op IUC Size and type of catheter used: 12 or 14F Foley catheter, Teflon‐coated Study definition of short‐term catheterisation (days): not reported |
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Outcomes | UTI Urinary retention Number of patients needing to be recatheterised |
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Definition of CAUTI or bacteriuria | 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. When there was a doubt, participants were defined as having UTI. |
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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 | A size 12 or 14 Fr transurethral Teflon‐coated Foley catheter was used for both groups. Post‐catheter removal all participants were encouraged to void spontaneously, those that could not were recatherised. A least 3 urine cultures were taken. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “… randomized by means of a nurse drawing a closed opaque envelope” Comment: no other information reported |
Allocation concealment (selection bias) | Low risk | Quote: “…closed opaque envelope” Comment: closed envelopes were used to conceal allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely that participants could be blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Suggests that urine samples were sent to a laboratory for microscopy and culture. Unlikely that microbiologist knew which patients belonged to the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported |
Selective reporting (reporting bias) | Low risk | All outcomes reported in methods are reported in full in results |
Other bias | Low risk | Appears to be free from other sources of bias |