Leek 2013

Methods	DESIGN: Randomised controlled cross‐over trial BLINDING PROCEDURES: 'Full blinding not possible, but microbiological data were entered by blinded staff' SAMPLE CALCULATION: Yes DURATION:16 weeks (8 weeks per arm) WITHDRAWALS/DROPOUTS: 3 participants dropped out ITT: Not applicable GEOGRAPHICAL LOCATION: Australia SETTING: Hospital outpatient pelvic floor clinic
Participants	N = 23 DIAGNOSIS: Varied ELIGIBLE: 41 ENROLLED: 23 COMPLETED: 20 AGE: Adults GENDER: 6 male, 17 female
Interventions	Uncoated catheter, non‐lubricated and clean technique both arms
Outcomes	Asymptomatic and symptomatic UTI with microbiological confirmation
Notes	No statistically significant difference in the rate of symptomatic UTI at week 8 or 16.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'Computer‐generated randomisation code'
Allocation concealment (selection bias)	Low risk	'Opaque sequentially numbered sealed envelopes'
Blinding of participants and personnel (performance bias) All outcomes	Low risk	'Full blinding not possible, but microbiological data entered by blinded staff'. Risk of performance bias considered low as cross‐over trial.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Risk of detection bias considered low as cross‐over trial.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Incomplete data for 3 participants
Source of Funding	Unclear risk	Not stated