Methods |
DESIGN: Randomised controlled cross‐over trial BLINDING PROCEDURES: Single blind (to investigator) SAMPLE CALCULATION: Yes DURATION: 2 days WITHDRAWALS/DROPOUTS: Not stated ITT: Not applicable GEOGRAPHICAL LOCATION: Denmark SETTING: Outpatient clinic |
Participants |
N = 24 DIAGNOSIS: Spinal cord lesion ELIGIBLE: Not stated ENROLLED: 24 COMPLETED: 24 AGE: Adults GENDER: Female |
Interventions |
Short length female catheter (hydrophilic coated) versus standard length (various designs) female catheter |
Outcomes |
Residual urine measured by ultrasound, satisfaction, handling, suitability of length |
Notes |
No difference in residual urine outcomes, satisfaction or ease of handling |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Participants were randomised in blocks of four" |
Allocation concealment (selection bias) |
Unclear risk |
Not stated |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
"Single‐blind". Not possible to blind participants, but outcome assessment was blinded and the non‐blinding of participants was considered unlikely to introduce bias. |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
"Study nurse (who carried out the ultrasound) was not present during the catheterization in order to remain blinded regarding the type of catheter used". participant‐reported handling and satisfaction of catheter and was unblinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
No missing outcome data. |
Source of Funding |
Unclear risk |
Coloplast A/S |