Alessandri 2006.

Study characteristics
Methods	Study design: RCT Dates study conducted: September 2003‐March 2004
Participants	Number of participants: 96 eligible; 96 randomised; 94 reported Setting: Genova Country: Italy Population: women Age (mean (SD), N): A 51 (4.3), 32; B 49 (3.7), 30; C 47 (5.0), 32 Inclusion criteria: women having hysterectomy for benign diseases (fibroids, abnormal uterine bleeding, and persistent cervical dysplasia) Condition for hospitalisation: vaginal hysterectomy Exclusion criteria: anticipated complicated surgical procedure (e.g. uterine prolapse, bladder suspension or colporrhaphy, diagnosis suspicious for malignant disease or severe endometriosis); recurrent UTIs (significant bacteriuria, determined by urine culture and defined as at least 105 cfu/mL of urine) and/or urinary incontinence; neurological disorders Use of antibiotic prophylaxis: women received a single dose of antibiotic prophylaxis before operation
Interventions	A (n = 32): immediate removal of IUC in the operating room B (n = 30): removal of IUC at 6 h after the operation C (n = 32): removal of IUC at 12 h after the operation Size and type (e.g. silver‐coated/PTFE) of catheter used: 16F latex catheters with a 10 mL balloon Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group (h): A: Duration of surgical procedure B: Duration of surgical procedure + 6 h C: Duration of surgical procedure + 12 h
Outcomes	Number of women requiring re‐catheterisation after operation Number of women with symptomatic UTIs Time to first ambulation Length of hospital stay
Definition of CAUTI or bacteriuria	Significant bacteriuria, determined by urine culture and defined as at least 105 cfu/mL of urine
Sponsorship/funding	Not reported
Ethical approval	Informed consent obtained. Protocol approved by hospital’s ethics committee
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed by using a computer‐generated randomization list drawn up by a statistician and concealed by keeping it with the nurse." Comment: adequate method of randomisation
Allocation concealment (selection bias)	Low risk	Quote: "Before entering the operating room, the surgeon received from the theatre nurse a sealed opaque envelope that contained the randomization assignment. In all cases, the envelope was opened at the end of the surgical procedure." Comment: adequate method of concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Not possible ‐ Although our findings are strengthened by the fact the surgeon was made aware of the randomization only at the end of the operation, a limitation of our study may consists in the fact that the observers of outcome were not blinded to the randomization" Comment: blinding of participants was not possible due to the intervention
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "the observers of outcome were not blinded to the randomization" Comment: blinding of outcome assessment not possible
Blinding of microbiological outcome (detection bias)	Low risk	Not reported Comment: likely samples were sent to a laboratory and thus unlikely that microbiologist knew which patient was in the study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Two patients in group B were excluded from the study because of the necessity of an unanticipated complicated surgical procedure (bladder suspension during VH)" Comment: low attrition and not differential
Selective reporting (reporting bias)	Low risk	All outcomes reported in methods and reported in full in the results section. However, protocol was not available for assessment
Other bias	Low risk	Appears to be free from other sources of bias