| Methods | DESIGN: Randomised controlled trial BLINDING PROCEDURES: Double blind SAMPLE CALCULATION: Yes DURATION: 4 weeks WITHDRAWALS/DROPOUTS: Unclear ITT: Yes and also per protocol analysis GEOGRAPHICAL LOCATION: 6 European countries (13 centres) SETTING: Community | |
| Participants | N = 195 DIAGNOSIS: Mixed ELIGIBLE: Not stated ENROLLED: 195 COMPLETED: Unclear AGE: Adults GENDER: 151 male; 44 female | |
| Interventions | Hydrophilic‐coated catheter, not activated, sterile water provided versus hydrophilic‐coated catheter, not activated, water added by user (aseptic technique both arms) | |
| Outcomes | Participant perception of handling | |
| Notes | Participant perception of handling was rated similarly in both groups | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Since most polymeric materials are visually similar, comparable materials could be produced and packaged in identical form". This was set up as a double‐blind trial. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | This was set up as a double‐blind trial. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar incomplete outcome data in control (n = 6) and intervention (n = 10) groups |
| Source of Funding | Unclear risk | Not stated |
BPH: benign prostatic hyperplasia CFU/mL: colony‐forming unit per millilitre CIC: Clean Intermittent Catheterization C&S: culture and sensitivity IC: intermittent catheterisation ICU: intensive care unit ISC‐Q: Intermittent Self‐Catheterisation Questionnaire ITT: intention‐to‐treat NIDRR: National Institute on Disability and Rehabilitation Research RBC per HPF: red blood cell per RCT: randomised controlled trial SS: UI: urinary infection UTI: urinary tract infection VAS: visual analogue scale