Sekhavat 2008.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: December 2002‐November 2004 |
|
| Participants |
Number of participants: eligible, not reported; 90 randomised; 90 reported Country: Iran Population: women Age (mean and SD): A 38.9 ± 2.9; B 39 ± 3.8 Inclusion criteria: women who underwent anterior repair Condition for hospitalisation: anterior colporrhaphy (pelvic organ prolapse) Exclusion criteria: not reported Use of antibiotic prophylaxis: in addition, the first dose of 1 mg cephalexin was given immediately before the beginning of operation and the second, given 6 h after the initial dose. |
|
| Interventions |
Group A (n = 45): IUC removed straight after surgery Group B (n = 45): IUC removed 24 h after surgery Size and type of catheter used: 16F Foley catheter with 10 mL balloon, latex Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC removed immediately post‐op B: IUC removed at least 24 h post‐op |
|
| Outcomes | UTI Urinary retention Voided spontaneously Number needing to be recatheterised (reported as in and out catheterisation) Ambulation time post‐op (h) Hospital stay (h) Urinary discomfort |
|
| Definition of CAUTI or bacteriuria | The prevalence of symptomatic UTI was confirmed, detected in the urine culture by a positive urine culture or through urinary signs such as burning urination, frequency, urgency, suprapubic pain and fever. | |
| Sponsorship/funding | Not reported | |
| Ethical approval | The adopted protocol was approved by the hospital research and ethics committee | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “The patients were randomly (the randomisation schedules were prepared using a computer‐generated random number table)…” Comment: computer‐generated randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely that this was possible. No blinding reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Assume microbiologist was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “All women enrolled in the study were included in the analysis” Comment: no withdrawals reported |
| Selective reporting (reporting bias) | Low risk | All outcomes outlined in methods are reported in full in results section. However, protocol was not available for analysis |
| Other bias | Low risk | Appears to be free from other sources of bias |