Alonzo‐Sosa 1997.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: March‐November 1994 |
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| Participants |
Number of participants: eligible, not reported; 50 randomised; 50 reported Country: Mexico Population: women Age (mean (range)): A 53.5 (37‐63); B 47.1 (37‐67) Inclusion criteria: women booked for elective corrective surgery of the pelvic floor (anterior colporrhaphy, anterior and posterior colporrhaphy with or without vaginal hysterectomy) Condition for hospitalisation: pelvic floor surgery with or without vaginal hysterectomy Exclusion criteria: patients with UTI were not included Use of antibiotic prophylaxis: "Antibiotic prophylaxis was not given" |
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| Interventions |
Group A (n = 25): IUC for 1 day post‐op Group B (n = 25): IUC for 3 days post‐op Size of catheter used: 16F catheter Type of indwelling catheter: not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group (h): Group A: 1 day Group B: 3 days |
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| Outcomes | AUR/number needing re‐catheterisation (%) UTI (%) Duration of catheterisation Length of hospital stay |
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| Definition of CAUTI or bacteriuria | A positive urine sample was defined as the presence of > 100,000 cfu/mL if taken mid‐stream and 10,000 cfu/mL in a sample taken by catheterisation. UTI was defined as positive sample associated with dysuria, polyuria, incomplete emptying, pain, fever or sepsis. Asymptompatic bacteriuria was defined as a positive sample in the absence of symptoms. |
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| Sponsorship/funding | Not reported | |
| Ethical approval | Not reported | |
| Notes | "After removing the catheter, the volume of residual urine was measured and if greater than 50mL was considered urinary retention and another foley catheter was inserted, with patients removed from the study and brought to restoration of normal bladder function" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomised controlled blinded clinical trial ..." Comment: unclear as to how randomisation was performed |
| Allocation concealment (selection bias) | Unclear risk | Not reported Comment: unclear as to whether allocation concealment was performed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Randomised controlled blinded clinical trial ..." Comment: unclear as to who was blinded and how blinding was performed. Unlikely blinding was possible due to the type of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported Comment: assume microbiologist would be blinded as samples would be sent to a laboratory where the microbiologist would not know which patient belonged to the trial. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of incomplete outcome data bias |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting bias |
| Other bias | Low risk | No evidence of other bias identified |