Methods |
DESIGN: Randomised controlled trial ALLOCATION: Not described but did stratify participants according to presence/ absence of UTI and trial site. BLINDING PROCEDURES: Unclear SAMPLE CALCULATION: Yes post hoc DURATION: 3 months FOLLOW‐UP: days 2, 4, 6, 10, 15, 60 & 90 WITHDRAWALS/DROPOUTS: 2 ITT: Not stated GEOGRAPHICAL LOCATION: USA SETTING: 3 long‐term care Veterans Administration Medical Centre Nursing Homes |
Participants |
N = 80 DIAGNOSIS: Incomplete bladder emptying due to prostate obstruction ELIGIBLE: 203 ENROLLED: 82 COMPLETED: 80 to day 15; 39 completed to Day 90) AGE: Elderly GENDER: Male |
Interventions |
Sterile technique vs clean technique (also single vs multiple use): sterile equipment and procedure, cleaning with betadine; Clean technique: catheter washed with soap and water and reused x 1 week (uncoated, non‐lubricated catheters) |
Outcomes |
Number of treatment episodes for UTI + urinalysis. |
Notes |
Some participants had indwelling catheters prior to enrolment in the trial (not stated how many); weeks to onset of symptomatic UTI was 3.11 (3.12) for treatment and 3.5 (3.02) for control. Dropout rate high after Day 15 with only 39 completing data collection to Day 90. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
"Randomly assigned" |
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 |
No blinding of outcome assessment ‐ this may have resulted in bias |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
All participants had full dataset for Day 15, but missing outcome data at end of 90 days |
Source of Funding |
Low risk |
Dept of Veterans Affairs US. |