Guzman 1994.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: January 1990‐December 1991 |
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Participants |
Number of participants: eligible, not reported; 106 randomised; 106 reported Setting: Gynaecology Unit of Valdivia Regional Hospital Country: Chile Population: women Age (mean and range): Group A 56 (40‐75); Group B 58 (8‐79); Group C 57 (36‐75) Inclusion criteria: women undergoing vaginal surgery Condition for hospitalisation (e.g. hysterectomy or TURP): vaginal conditions (74 had complete genital prolapse of grade 2 or 3 and 32 had grade 2 or 3 cystoceles) Use of antibiotic prophylaxis: all patients received Quemicetina as antibiotic prophylaxis |
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Interventions |
Group A (n = 37): removal of IUC within 24 h Group B (n = 36): removal of IUC at 72 h Group C (n = 33): removal of IUC at 72 h plus bladder re‐training, which involved intermittent clamping of the catheter Size and type of catheter used (e.g. Foley 16F): 14F with 10 mL balloon, latex Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: 1 day (no clamping regime) Group B: 3 days (no clamping regime) Group C: 3 days (with clamping regime) |
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Outcomes | Urinary retention Re‐installation of Foley catheter Urine culture > 100,000 cfu Average days spent in hospital (median) |
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Definition of CAUTI or bacteriuria | Not reported | |
Sponsorship/funding | Not mentioned | |
Ethical approval | Not specified | |
Notes | Urinary retention defined as residual urine volume of > 100 mL for 2 consecutive micturitions UTI defined by urine cultures All participants were administered prophylactic antibiotics Size of urethral catheter 14F Foley |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: method of randomisation not specified |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely that blinding was possible due to the nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Assume cultures were sent to a laboratory and so microbiologist would not know which patient belonged to the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence to suggest incomplete data |
Selective reporting (reporting bias) | Low risk | No evidence for selective reporting |
Other bias | Low risk | No other source of bias identified |