Pervaiz 2019.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: January 2018‐June 2018 |
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| Participants |
Population: men Setting: Lahore Country: Pakistan Inclusion criteria: men between 50‐80 years of age presenting with benign prostate enlargement (history of difficulty in micturition for at least 1 month) undergoing TURP Condition for hospitalisation: TURP Exclusion criteria: abnormal coagulation profile (prothrombin time (PT) > 15 sec; activated partial thromboplastin time (APTT) > 35 s), patients with systemic problems like BP > 140/90 mmHg, blood sugar range > 200 mg/dL, abnormal echocardiogram and ejection fraction < 55% on echocardiography, very large prostate (> 100 g) Number of participants: 100 eligible; 100 randomised; 100 reported Age (mean and SD): A 67.00 ± 9.11; B 65.56 ± 9.25 Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 50): IUC removal day 1 post‐op Group B (n = 50): IUC removal day 4 post‐op Size and type of catheter used: 3‐way Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: removal on post‐op day 1 Group B: removal on post‐op day 4 |
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| Outcomes | Number of participants requiring recatheterisation UTI |
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| Definition of CAUTI or bacteriuria | Urine sample was obtained to assess UTI (bacterial colony count >105 cfu/mL on urine culture after removal of catheter assessed on day 7) | |
| Sponsorship/funding | Not reported | |
| Ethical approval | Not reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Then patients were randomly assigned in two sets by utilizing lottery technique.” Comment: adequate randomisation method |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely possible given nature of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Assume lab technician was blinded to participants belonging to the trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No exclusions or withdrawals |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in methods reported in results. Protocol not available for assessment |
| Other bias | Low risk | Appears to be free from other sources of bias |