Giannantoni 2001

Methods	DESIGN: Randomised controlled cross‐over trial BLINDING PROCEDURES: Not clear SAMPLE CALCULATION: No DURATION: 7 weeks each arm FOLLOW‐UP: Urine for C&S at 2, 4, 7 weeks WITHDRAWALS/DROPOUTS: Not stated ITT: Not applicable GEOGRAPHICAL LOCATION: Italy SETTING: Rehabilitation Hospital
Participants	N = 18 DIAGNOSIS: Neurogenic bladder due to recent spinal cord injury ELIGIBLE: Unknown ENROLLED: 18 COMPLETED: 18 AGE: Adults GENDER: 16 male & 2 female
Interventions	Coated vs uncoated: Pre‐lubricated catheter with protective sleeve versus an uncoated, non‐lubricated catheter (water added by user); one catheter x 7 weeks then cross‐over to other group.
Outcomes	UTI measured by C&S at 2, 4 & 7 weeks; Urethral wall trauma by counting cells on catheter surface; VAS re: satisfaction with catheters
Notes	UTI defined as cloudy, odorous urine, onset of UI, increase autonomic dysreflexia, pyuria, bacteriuria; Sample size too small to draw conclusions. Attempted randomisation concealment; higher % of UTI in PVC group; no difference in urethral cell count; unable to use data in Table of Comparisons because of cross‐over design and no mid‐point data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"One of us organised randomisation"
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No blinding, but the review authors judge that the outcome and outcome measurement are not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data
Source of Funding	Unclear risk	Not stated