Iversen Hansen 1984.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: not reported |
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| Participants |
Number of participants: 66 eligible; randomised, not reported; 43 reported Country: Denmark Population: unclear Age (median and range): 70 (24‐85) Inclusion criteria: patients with urethral strictures Condition for hospitalisation (e.g. hysterectomy or TURP): urethral strictures Exclusion criteria: not reported Use of antibiotic prophylaxis: antibiotics were not administered routinely but patients with urinary infections pre‐ or post‐operatively were treated with antibiotics according to urine culture. |
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| Interventions |
Group A (n = 21): IUC treatment for 1 day Group B (n = 22): IUC treatment for 14 days Size and type of catheter used (e.g. Foley 16F): unclear. Retrograde urethrography was performed with a 10F Foley catheter with balloon Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: IUC treatment for 1 day post‐op B: IUC treatment for 14 days post‐op |
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| Outcomes | Complication rate Recurrence of strictures using maximal flow rate ≤ 12 (mL/second) Recurrence of strictures using urethrography Restenosis Patient satisfaction |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | Not reported | |
| Notes | All participants had voiding interview, flowmetry and retrograde urethrography performed pre‐operatively as well as 3 and 6 months post‐operatively. A Disa flowmeter, type 517B was used for flowmetry Antibiotics were administered only to participants with UTI 23 participants did not complete the operative and post‐operative programme Information regarding reasons for withdrawals and losses to follow‐up provided |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “For the operation, patients were randomly allocated into two groups …” Comment: randomisation performed although method of randomisation is not stated |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Blinding of participants unlikely to be possible in this situation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Quote: “Urinary infections pre‐ or postoperatively were treated with antibiotics according to urine culture …” Comment: suggests that urine samples were sent to a laboratory. Unlikely the microbiologists knew which patient belonged to the trial |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: “Of the 66 patients admitted to the study, 23 patients did not complete the operative and post‐operative programme.” Comment: large withdrawal numbers. Reasons for withdrawal given but not reported in relation to intervention group |
| Selective reporting (reporting bias) | High risk | Outcomes are not reported in methods and are reported in the results section only. Protocol not available for assessment |
| Other bias | Low risk | Appears to not be at risk of any other bias |