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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.