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Table 2 Patient outcomes at six weeks post-stroke

From: Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial

  Trial arm  
Usual care (UC) Intervention (I) Odds ratio (95% CI) I versus UCe Supported implementation (SI) Odds ratio (95% CI) SI versus UCe All sites Intracluster Correlation Coefficient (ICC)c
Questionnaires returned 96   122    88    306   
Catheterised (% of returned) 21 22% 37 30%   18 20%   76 25%  
Potential respondents for incontinence measures (% age of returned) 75 78% 85 70%   70 80%   230 75%  
Primary outcome: presence or absence of incontinence (ICIQ-UI Short-Form question three)      0.94 (0.46-1.94)    0.62 (0.28-1.37)    0
Continenta 21 28% 29 34%   16 23%   66 29%  
Incontinentb 54 72% 56 66%   54 77%   164 71%  
ICIQ-UI Short Form (UC: 75; I: 83; SI: 70; All: 228)f      0.83 (0.49-1.38)    0.89 (0.52-1.51)    0
Never 21 30% 29 41%   16 24%   66 31%  
About once a week or less often 8 11% 7 10%   11 16%   26 12%  
Two or three times per week 12 17% 10 14%   8 12%   30 14%  
About once a day 9 13% 11 15%   12 18%   32 15%  
Several times a day 25 35% 25 35%   22 32%   72 34%  
All the time 0 0% 1 1%   1 1%   2 1%  
Secondary outcomes            
Incontinence Severity Index (ISI) score (UC: 75; I: 84; SI: 68; All: 227)f      0.87 (0.48-1.57)    0.84 (0.46-1.56)    0
Median (IQR) 4 0-8 4 0-8   4 1-8   4 (0-8)  
None (0) 21 28% 29 35%   16 24%   66 29%  
Slight (1-2) 6 8% 6 7%   7 10%   19 8%  
Moderate (3-4) 13 17% 11 13%   18 26%   42 19%  
Severe (6-8) 35 47% 38 45%   27 40%   100 44%  
Leicester Urinary Symptom Questionnaire            
Frequency of toilet visits during daytime (UC: 71; I: 71; SI: 68; All: 210)f      0.43 (0.22-0.84)    0.60 (0.30-1.22)    0.017
At least every 30 minutes 0 0% 0 0%   0 0%   0 0%  
Every hour 0 0% 0 0%   0 0%   0 0%  
Every 90 minutes 2 3% 2 3%   1 1%   5 2%  
Every 2 hours 2 3% 2 3%   10 15%   14 7%  
Less often than every 2 hours 67 94% 67 94%   57 84%   191 91%  
Types of incontinence            
Urge incontinence present (UC: 75; I: 84; SI: 68; All: 227)f 52 70% 50 59% 1.35 (0.67-2.71) 48 71% 0.89 (0.41-1.91) 150 66% 0
Stress incontinence present (UC: 71; I: 78; SI: 57; All: 206)f 36 51% 32 41% 1.01 (0.42-2.43) 33 58% 0.82 (0.34-1.61) 101 49% 0
EQ-5D-3 L            
Mobility (UC: 96; I: 114; SI: 88; All: 298)f      1.27 (0.69-2.34)    1.37 (0.74-2.53)    
No problems 13 14% 10 9%   6 7%   29 10%  
Some problems 51 53% 44 39%   48 55%   143 48%  
Confined to bed 32 33% 60 53%   34 39%   126 42%  
Self-care (UC: 96; I: 114; SI: 88; All: 298)f      0.61 (0.34-1.09)    0.75 (0.40-1.39)    0
No problems 13 14% 13 11%   13 15%   39 13%  
Some problems 49 51% 47 41%   36 41%   132 44%  
Unable to wash or dress 34 35% 54 47%   39 44%   127 43%  
Usual activity (UC: 96; I: 114; SI: 88; All: 298)f      0.42 (0.22-0.81)    0.79 (0.41-1.51)    0
No problems 6 6% 5 4%   5 6%   16 5%  
Some problems 44 46% 30 26%   34 39%   108 36%  
Unable to perform 46 48% 79 69%   49 56%   174 58%  
Pain or discomfort (UC: 95; I: 111; SI: 84; All: 290)f      0.66 (0.38-1.16)    0.63 (0.34-1.14)    0
None 62 65% 58 52%   52 62%   172 59%  
Moderate 32 34% 48 43%   29 35%   109 38%  
Extreme 1 1% 5 5%   3 4%   9 3%  
Anxiety or depression (UC: 95; I: 107; SI: 83; All: 285)f      0.56 (0.33-0.95)    0.86 (0.49-1.51)    0
None 51 54% 47 44%   47 57%   145 51%  
Moderate 42 44% 54 50%   33 40%   129 45%  
Extreme 2 2% 6 6%   3 4%   11 4%  
Mean (SD) incontinence Quality of lifed (UC: 53; I: 43; SI: 38; All: 134)f 75 (56.7-90.9) 78.4 (37.5-89.8) -10.1 (-29.5-9.3) 74.4 (48.3-92.1) -10.1 (-28.6-8.3) 76 (51.7-91.2) 0.184
Median (IQR) Barthel Index (UC: 96; I: 117; SI: 88; All: 301)f 8.5 (3-14) 7 (3-11) 0.68 (0.43-1.07) 7.5 (4-12) 0.70 (0.43-1.13) 8 (3-12) 0
Dead (UC: 118; I: 145; SI: 114; All: 377)f 4 3% 7 5% 1.01 (0.43-2.39) 6 5% 0.72 (0.31-1.71) 17 5% 0.0087
  1. aDefined as never on the ICIQ-UI Short Form response question three.
  2. bDefined as any non-missing response other than ‘never’ on the ICIQ-UI Short Form.
  3. cAny ICC estimate <10-6 is presented as 0.
  4. dExcluding participants recorded as continent or catheterised.
  5. eORs based on imputed data; values >1 favour I or SI over UC.
  6. fData available for UC, I, SI, and all sites.