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Table 3 Patient outcomes at 12 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 (OR) (95% CI) I versus UCe Supported implementation OR (95% CI) SI versus UCe All sites Intracluster Correlation Coefficient (ICC)c
Questionnaires returned 98   132    100    330   
Catheterised (% of returned) 18 18% 27 20%   13 13%   58 17%  
Potential respondents for incontinence measures (% age of returned) 80 82% 105 80%   86 86%   271 82%  
Primary outcome: presence or absence of incontinence (ICIQ-UI Short-Form question three)            
Continenta 24 30% 43 41% 1.02 (0.54-1.93) 27 31% 1.06 (0.54-2.09) 94 35% 0
Incontinentb 56 70% 62 59%   59 68%   177 65%  
ICIQ-UI Short Form (UC: 80; I: 104; SI: 86; All: 270)f      0.97 (0.58-1.61)    1.22 (0.72-2.08)    0
Never 24 30% 43 41%   27 31%   94 35%  
About once a week or less often 12 15% 9 9%   10 12%   31 12%  
Two or three times per week 12 15% 13 12%   11 13%   36 13%  
About once a day 12 15% 6 6%   10 12%   28 10%  
Several times a day 18 23% 25 24%   27 31%   70 26%  
All the time 2 3% 8 8%   1 1%   11 4%  
Secondary outcomes            
Incontinence Severity Index (ISI) score (UC: 80; I: 102; SI: 86; All: 268)f      0.86 (0.50-1.50)    0.92 (0.52-1.64)    0
Median (IQR) 3 (0-6) 2.5 (0-8)   4 (0-8)   3 (0-8)  
None (0) 24 30% 43 42%   28 33%   95 35%  
Slight (1-2) 10 13% 8 8%   6 7%   24 9%  
Moderate (3-4) 19 24% 12 12%   17 20%   48 18%  
Severe (6-8) 27 34% 39 38%   35 41%   101 38%  
Leicester Urinary Symptom Questionnaire            
Frequency of toilet visits during daytime (UC: 73; I: 88; SI: 71; All: 232)f      0.85 (0.47-1.54)    1.09 (0.60-1.96)    0.0075
At least every 30 minutes 0 0% 0 0%   0 0%   0 0%  
Every hour 0 0% 0 0%   1 1%   1 0%  
Every 90 minutes 5 7% 2 2%   4 6%   11 5%  
Every 2 hours 10 14% 11 13%   6 8%   27 12%  
Less often than every 2 hours 58 79% 75 85%   60 85%   193 83%  
Type of incontinence            
Urge incontinence present (UC: 79; I: 103; SI: 85; All: 267)f 53 67.1% 52 50.5% 1.58 (0.83-2.99) 49 57.6% 1.73 (0.88-3.43) 154 57.7% 0
Stress incontinence present (UC: 72; I: 83; SI: 72; All: 227)f 38 52.8% 29 34.9 1.04 (0.45-1.82) 31 43.1 1.82 (0.82-4.01) 98 43.2% 0
EQ-5D-3 L            
Mobility (UC: 96; I: 129; SI: 92; All: 317)f      0.92 (0.52-1.62)    0.79 (0.44-1.41)    0
No problems 19 20% 16 12%   10 11%   45 14%  
Some problems 53 55% 62 48%   57 62%   172 54%  
Confined to bed 24 25% 51 40%   25 27%   100 32%  
Self-care (UC: 97; I: 126; SI: 92; All: 315)f      0.45 (0.26-0.79)    0.65 (0.36-1.16)    0
No problems 25 26% 21 17%   18 20%   64 20%  
Some problems 42 43% 47 37%   40 43%   129 41%  
Unable to wash or dress 30 31% 58 46%   34 37%   122 39%  
Usual activities (UC: 97; I: 126; SI: 91; All: 314)f      0.49 (0.27-0.90)    0.63 (0.34-1.17)    0
No problems 10 10% 9 7%   8 9%   27 9%  
Some problems 43 44% 39 31%   32 35%   114 36%  
Unable to perform 44 45% 78 62%   51 56%   173 55%  
Pain or discomfort (UC: 95; I: 123; SI: 93; All: 311)f      0.73 (0.43-1.23)    0.88 (0.50-1.54)    0
None 55 58% 51 41%   50 54%   156 50%  
Moderate 37 39% 58 47%   34 37%   129 41%  
Extreme 3 3% 14 11%   9 10%   26 8%  
Anxiety or depression (UC: 95; I: 122; SI: 92; All: 309)f      0.67 (0.39-1.13)    0.95 (0.54-1.67)    0
None 53 56% 47 39%   47 51%   147 48%  
Moderate 37 39% 66 54%   37 40%   140 45%  
Extreme 5 5% 9 7%   8 9%   22 7%  
Mean (SD) Incontinence Quality of Lifed (UC: 51; I: 47; SI: 35; All: 133)f 72.6 (58.3-83.0) 76.1 (42.5-94.3) -5.5 (-24.1-13.1) 67.1 (51.1-85.2) -1.9 (-21.2-17.4) 72.6 (52.9-87.5) 0.216
Median (IQR) Barthel Index (UC: 94; I: 128; SI: 95; All: 317)f 11 (4-16) 8 (4-13) 0.71 (0.46-1.11) 11 (6-15) 0.97 (0.61-1.54) 10 (4-15) 0
Dead (UC: 123; I: 159; SI: 122; All: 404)f 12 10% 16 10% 1.04 (0.56-1.92) 10 8% 1.15 (0.60-2.19) 38 9% 0
  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.