Matsushima 2015.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: March 2012‐September 2014 |
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| Participants |
Number of participants: 125 eligible; 119 randomised; 113 reported Country: Japan Population: men Age (mean ± SD): overall mean 65.9 ± 5.5 Inclusion criteria: localised prostate cancer without lymph node and distant metastasis and age < 75 years Condition for hospitalisation: prostate cancer Exclusion criteria: previous radiotherapy; previous prostatic; bladder neck; urethral, or pelvic surgery; presence of an IUC Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 60): IUC removed on post‐op day 2 Group B (n = 59): IUC removed on post‐op day 4 Size and type of catheter used: 20‐Fr Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A 2 days; B 4 days |
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| Outcomes | AUR/recatheterisation Urinary incontinence (data related to treatment of cancer and not catheterisation); Continence (defined as a pad‐free status) Serious complications Intraoperative urine leakage |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | Ethical approval for the design of this study was granted by the Keio University Hospital Ethical Committee. Written informed consent was obtained from all patients prior to participation in this study | |
| Notes | This study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000014944) on 12 March 2012 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Randomization was carried out after consent using a computer generated random table by an independent researcher who was not directly involved with the study.” Comment: adequate method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “Blinding was not possible in this trial because the timing of catheter removal was different.” Comment: blinding was not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Not reported. No microbiological outcomes measured |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3/60 and 3/59 excluded from analysis because of “extravasation”. Comment: unclear how this will affect the outcome measures |
| Selective reporting (reporting bias) | Low risk | All outcomes mentioned in methods are reported in results |
| Other bias | Low risk | Appears free from other sources of bias |