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Table 4 Summary of numeric outcome measures by trial arm and data collection time-point

From: A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study

 

IUT

no IUT

Overall completion ratea

 

Baseline

6 months

Baseline

6 months

Baseline

6 monthsb

Questionnaire (possible scores)

n

Mean (SD)

Median (IQR)

Range

n

Mean (SD)

Median (IQR)

Range

n

Mean (SD)

Median (IQR)

Range

n

Mean (SD)

Median (IQR)

Range

Partial n (%)

Complete n (%)

Partial n (%)

Complete n (%)

ICIQ-FLUTS Overall score (0–48)

77

16.9 (5.7)

17 (13–21)

4–37

47

9.2 (7.5)

8 (4–12)

0–38

85

16.4 (6.3)

16 (11–21)

3–34

66

6.9 (5.0)

6 (3–9)

0–26

3 (2)

162 (98)

5 (4)

113 (90)

Subscales:

                    

 Filling  (0–16)

78

4.4 (2.3)

4 (3–6)

0–11

48

3.0 (2.3)

3 (1–4)

0–11

85

4.0 (2.6)

3 (2–6)

0–10

66

2.4 (1.8)

2 (1–3)

0–8

2 (1)

163 (99)

3 (3)

114 (91)

 Voiding  (0–12)

79

1.8 (2.0)

1 (0–3)

0–9

49

2.0 (2.0)

2 (0–3)

0–9

86

1.5 (1.7)

1 (0–2)

0–9

68

2.3 (2.1)

2 (0–4)

0–8

0 (0)

165 (100)

1 (1)

117 (94)

 Incontinence  (0–20)

78

10.8 (3.3)

11 (8–13)

2–19

49

4.0 (4.9)

3 (1–5)

0–20

86

10.8 (3.6)

11 (8–13)

2–19

68

2.3 (3.1)

2 (0–3)

0–16

1 (1)

164 (99)

1 (1)

117 (94)

 ICIQ-UI SF  (0–21)

78

14.0 (3.7)

14 (12–16)

4–21

49

5.3 (6.0)

3 (0–8)

0–21

85

14.1 (3.8)

15 (12–17)

4–21

65

3.3 (4.5)

1 (0–4)

0–18

2 (1)

163 (99)

3 (3)

114 (91)

 ICIQ-LUTSqol  (19–76)

73

46.8 (10.9)

47 (40–52)

26–74

44

26.7 (12.3)

22 (20–28)

19–76

84

48.5 (11.7)

46 (39–58)

30–72

65

25.3 (9.6)

21 (20–28)

19–65

8 (5)

157 (95)

9 (7)

109 (87)

UDI

                    

 Overall score  (0-300)

64

133.3

(43.5)

133.5

(109–159)

25–245

42

49.1

(44.1)

37.1

(17–69)

0–191

74

130.1 (43.8)

125.8

(96–162)

50–227

59

33.9 (39.7)

24.2 (4–46)

0–150

27 (16)

138 (84)

17 (14)

101 (81)

Subscales:

                    

 Stress  (0–100)

76

82.9 (21.0)

87.5 (75–100)

25–100

50

24.5 (26.1)

25 (0–38)

0–100

80

80.2 (21.2)

87.5 (63–100)

38–100

65

18.1 (27.0)

0 (0–25)

0–100

6 (4)

156 (95)

2 (2)

115 (92)

 Irritative  (0–100)

71

38.4 (25.4)

33.3 (17–54)

0–100

48

16.5 (20.5)

8.3 (0–25)

0–100

80

33.7 (24.3)

31.3 (17–50)

0–92

64

10.0 (13.3)

4.2 (0–17)

0–54

13 (8)

151 (91)

6 (5)

112 (90)

 Obstructive/ discomfort  (0–100)

68

17.6 (17.6)

13.6 (6–23)

0–73

43

10.9 (15.1)

4.6 (0–18)

0–64

80

14.8 (14.2)

13.6 (3–20)

0–61

64

8.9 (12.4)

2.3 (0–14)

0–57

17 (10)

148 (90)

11 (9)

107 (86)

  1. ICIQ-FLUTS, International Consultation on Incontinence Female Lower Urinary Tract Symptoms questionnaire; UDI, Urogenital Distress Inventory; SD Standard deviation; IQR Interquartile range; IUT, invasive urodynamic testing (intervention) arm; no IUT, no invasive urodynamic testing (control) arm
  2. aComplete responses are defined as women who completed all questions on the particular questionnaire scale, and partial responses as those who completed at least one question but did not fully complete the particular scale
  3. bIn addition to complete and partial responses, there were seven completely blank questionnaires among the 6-month responses
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ISSN: 1745-6215