Tang 2006.
| Methods |
RCT or quasi‐RCT: RCT Setting: women's geriatric rehabilitation ward of a convalescent hospital, China Period: June 1999 ‐ December 2000 |
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| Participants |
Population: elderly women admitted to a convalescent hospital Inclusion criteria: women, > age 65, with PVR persistently > 300 ml by bladder scan ultrasound, admitted to a geriatric rehab ward Exclusion criteria: Terminally‐ill patients; indwelling catheter required for continuous monitoring of urine output Age (mean, SD): A: 81.4 (8.9); B: 80.0 (6.8) Number of participants:
Dropouts (n of participants + reasons): 15 participants were lost (A: 6/45; B: 9/36), with the main reason "for dropout was transfer to an acute hospital and clinical deterioration". 1 in group B refused further intermittent catheterisation from day 2. 1 in group B switched to indwelling catheterisation due to bilateral hydronephrosis. 2 in group A died. |
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| Interventions | A (n = 45): Indwelling Foley catheter, placed after randomisation. Removed at least once weekly, replaced if PVR > 300 ml B (n = 36): CISC, monitored by bladder scan 3 times a day. CISC performed when PVR > 500 ml or > 300 ml and symptomatic |
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| Outcomes |
Primary outcome (symptomatic UTI): A: 0/34; B: 1/22 (P = 0.400) Definition of symptomatic UTI: Symptomatic UTI on day 14: either having a fever in the absence of other sites of infection with or without symptoms of dysuria or suprapubic discomfort Bacteriuria: A: 21/34; B: 14/22 (P = 0.888) Definition of bacteriuria: Growth of ≥ 10⁵ bacteria/ml on 14th day Proportion of participants catheter‐free with PVR < 150 ml on day 14: A: 27/39; B: 16/27 (P = 0.403) PVRU on day 14 (ml) (mean, SD): A: 54.4 (49.1); B: 77.6 (48.2) Time to become catheter‐free (mean, SD)(days): A: 9.2 (4.0); B: 8.6 (3.3) |
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| Sponsorship/Funding | Not reported | |
| Notes | CISC group catheterised a mean of 3 times a day Urine cultures sent on day 1 and day 14. Bacteriuria defined as 105 cfu/ml on culture. Symptomatic UTI defined as fever with or without dysuria or suprapubic pain. According to power analysis, required 80 participants to determine no significant difference between groups; after losses, there were not enough participants. Incomplete outcome data for 15 lost participants after randomisation, and missing data for bacteriuria. Not reported if used prophylactic antibiotics |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised by "random number table" ‐ not enough information |
| Allocation concealment (selection bias) | Unclear risk | No information given |
| Blinding of participants | High risk | No information given but as indwelling vs intermittent can assume no blinding |
| Blinding of personnel | High risk | No information given but as indwelling vs intermittent can assume no blinding |
| Blinding of microbiological outcome assessment | Low risk | Symptomatic UTI and bacteriuria would be assessed by microbiologist who would not know the type of catheter the participant had received |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 15 dropouts which are differential when you exclude women who died. Also incomplete data for secondary outcome measures |
| Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes in Methods are all reported in Results. Unable to access protocol, so some uncertainty about selective reporting |
| Other bias | Low risk | Appears to be free of other sources of bias |