Skip to main content

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.