Shahnaz 2016.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: 2013‐2015 |
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| Participants |
Number of participants: 70 randomised; 70 reported Setting: Martyrs Hospital in the Persian Gulf Country: Iran Population: women Age (mean and SD): A 39.4 ± 3.2; B 38.8 ± 2.8 Inclusion criteria: the inclusion criteria included prolapse of vaginal anterior with grades 2 and 3, age between 25‐49 years old, and body mass index of 19‐24 kg/m2 Condition for hospitalisation: pelvic organ prolapse Exclusion criteria: vaginal anterior prolapse grade 1 and 4, diabetes, connective tissue diseases, different kinds of true urinary incontinence, having a history of hysterectomy Use of antibiotic prophylaxis: “After the surgery, the antibiotic was not regularly given except for patients who had abnormal urinary symptoms and unusual urinary analysis in urinary sample 48 h after the surgery” |
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| Interventions |
Group A (n = 35): IUC removal 24 h after surgery Group B (n = 35): IUC removal 72 h after surgery Size and type of catheter used (e.g. Foley 16F): not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: 24 h after surgery Group B: 72 h after surgery |
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| Outcomes | Number of participants with urinary retention Number of participants requiring recatheterisation Positive urine culture Length of hospitalisation |
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| Definition of CAUTI or bacteriuria | Urine analysis and culture examination was done prior to surgery in all participants. The presence of positive urinary culture or > 100,000 cfu/mL of urine or > 10 pieces of leukocyte in each microscopy field was considered as a urinary infection. | |
| Sponsorship/funding | Not reported | |
| Ethical approval | “approved by the Institutional Ethical Review Board” | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Patients were randomized into two groups using computer‐generated randomized schedules” Comment: adequate randomisation method |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not possible with this intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Assume urine samples were sent to a laboratory where the microbiologist would not know which patients were in the trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data accounted for with no withdrawals/dropouts |
| Selective reporting (reporting bias) | Low risk | Outcomes seem to be reported in full |
| Other bias | Low risk | Appears to be free from other sources of bias |