Jeong 2014.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: April 2010‐July 2011 |
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| Participants |
Number of participants: eligible, not stated; 236 randomised; 218 reported in primary analysis, 207 in secondary analysis Setting: Seoul Country: Korea Population: men Age (e.g. mean and SD): Group A (intervention) 63.6 (6.6); Group B (control) 63.4 (8.0) Inclusion criteria: localised or locally advanced prostate cancer; undergoing robot‐assisted laparoscopic radical prostatectomy (RARP); able to provide written informed consent Condition for hospitalisation: RARP Exclusion criteria: patients must not have a history of treatment with alpha blockers within 4 weeks; patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate; patients must not have previously been diagnosed with neurogenic bladder; patients must not have hypersensitivity to trial drug or other alpha‐blockers; patients must not have the participation of other clinical trial within the past 3 months Use of antibiotic prophylaxis: not reported |
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| Interventions |
Group A (n = 118): treatment with 0.4 mg of tamsulosin from the day before RARP up until 14 days after surgery (tamsulosin group) Group B (n = 118): no tamsulosin treatment (control group) Size and type of catheter used (e.g. Foley 16F): 20 FR Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: IUC was removed on the 5th post‐op day for both groups |
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| Outcomes | ICS male short‐form questionnaire 2 weeks after surgery: voiding sum, incontinence sum, frequency score, nocturia score, QoL item Postvoid residual volume, 2 weeks after surgery (mL) IPSS 2 weeks after surgery (including total score, storage subscale, voiding subscale, IPSS QoL item) AUR (participants with AUR on post‐op day 5 (defined as a painful, palpable or percussable bladder, with the patient unable to pass any urine) Adverse events |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | This study was supported by Astellas Pharm, Co. | |
| Ethical approval | The study was approved by the local institutional review board and registered at the ClinicalTrial.gov website (ID: NCT01209988) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “… randomly assigned” Comment: mentions randomised but does not specify method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | No microbiological outcomes reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No differential attrition. Per‐protocol analysis only |
| Selective reporting (reporting bias) | Low risk | Outcomes in methods also presented in results section |
| Other bias | Low risk | Appears to be free from other sources of bias |