| 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 | Â | 132 | Â | Â | 100 | Â | Â | 330 | Â | Â |
Catheterised (% of returned) | 18 | 18% | 27 | 20% | Â | 13 | 13% | Â | 58 | 17% | Â |
Potential respondents for incontinence measures (% age of returned) | 80 | 82% | 105 | 80% | Â | 86 | 86% | Â | 271 | 82% | Â |
Primary outcome: presence or absence of incontinence (ICIQ-UI Short-Form question three) | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
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% | Â | 59 | 68% | Â | 177 | 65% | Â |
ICIQ-UI Short Form (UC: 80; I: 104; SI: 86; All: 270)f | Â | Â | Â | Â | 0.97 (0.58-1.61) | Â | Â | 1.22 (0.72-2.08) | Â | Â | 0 |
Never | 24 | 30% | 43 | 41% | Â | 27 | 31% | Â | 94 | 35% | Â |
About once a week or less often | 12 | 15% | 9 | 9% | Â | 10 | 12% | Â | 31 | 12% | Â |
Two or three times per week | 12 | 15% | 13 | 12% | Â | 11 | 13% | Â | 36 | 13% | Â |
About once a day | 12 | 15% | 6 | 6% | Â | 10 | 12% | Â | 28 | 10% | Â |
Several times a day | 18 | 23% | 25 | 24% | Â | 27 | 31% | Â | 70 | 26% | Â |
All the time | 2 | 3% | 8 | 8% | Â | 1 | 1% | Â | 11 | 4% | Â |
Secondary outcomes | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Incontinence Severity Index (ISI) score (UC: 80; I: 102; SI: 86; All: 268)f | Â | Â | Â | Â | 0.86 (0.50-1.50) | Â | Â | 0.92 (0.52-1.64) | Â | Â | 0 |
Median (IQR) | 3 | (0-6) | 2.5 | (0-8) | Â | 4 | (0-8) | Â | 3 | (0-8) | Â |
None (0) | 24 | 30% | 43 | 42% | Â | 28 | 33% | Â | 95 | 35% | Â |
Slight (1-2) | 10 | 13% | 8 | 8% | Â | 6 | 7% | Â | 24 | 9% | Â |
Moderate (3-4) | 19 | 24% | 12 | 12% | Â | 17 | 20% | Â | 48 | 18% | Â |
Severe (6-8) | 27 | 34% | 39 | 38% | Â | 35 | 41% | Â | 101 | 38% | Â |
Leicester Urinary Symptom Questionnaire | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Frequency of toilet visits during daytime (UC: 73; I: 88; SI: 71; All: 232)f | Â | Â | Â | Â | 0.85 (0.47-1.54) | Â | Â | 1.09 (0.60-1.96) | Â | Â | 0.0075 |
At least every 30 minutes | 0 | 0% | 0 | 0% | Â | 0 | 0% | Â | 0 | 0% | Â |
Every hour | 0 | 0% | 0 | 0% | Â | 1 | 1% | Â | 1 | 0% | Â |
Every 90 minutes | 5 | 7% | 2 | 2% | Â | 4 | 6% | Â | 11 | 5% | Â |
Every 2 hours | 10 | 14% | 11 | 13% | Â | 6 | 8% | Â | 27 | 12% | Â |
Less often than every 2 hours | 58 | 79% | 75 | 85% | Â | 60 | 85% | Â | 193 | 83% | Â |
Type of incontinence | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Mobility (UC: 96; I: 129; SI: 92; All: 317)f | Â | Â | Â | Â | 0.92 (0.52-1.62) | Â | Â | 0.79 (0.44-1.41) | Â | Â | 0 |
No problems | 19 | 20% | 16 | 12% | Â | 10 | 11% | Â | 45 | 14% | Â |
Some problems | 53 | 55% | 62 | 48% | Â | 57 | 62% | Â | 172 | 54% | Â |
Confined to bed | 24 | 25% | 51 | 40% | Â | 25 | 27% | Â | 100 | 32% | Â |
Self-care (UC: 97; I: 126; SI: 92; All: 315)f | Â | Â | Â | Â | 0.45 (0.26-0.79) | Â | Â | 0.65 (0.36-1.16) | Â | Â | 0 |
No problems | 25 | 26% | 21 | 17% | Â | 18 | 20% | Â | 64 | 20% | Â |
Some problems | 42 | 43% | 47 | 37% | Â | 40 | 43% | Â | 129 | 41% | Â |
Unable to wash or dress | 30 | 31% | 58 | 46% | Â | 34 | 37% | Â | 122 | 39% | Â |
Usual activities (UC: 97; I: 126; SI: 91; All: 314)f | Â | Â | Â | Â | 0.49 (0.27-0.90) | Â | Â | 0.63 (0.34-1.17) | Â | Â | 0 |
No problems | 10 | 10% | 9 | 7% | Â | 8 | 9% | Â | 27 | 9% | Â |
Some problems | 43 | 44% | 39 | 31% | Â | 32 | 35% | Â | 114 | 36% | Â |
Unable to perform | 44 | 45% | 78 | 62% | Â | 51 | 56% | Â | 173 | 55% | Â |
Pain or discomfort (UC: 95; I: 123; SI: 93; All: 311)f | Â | Â | Â | Â | 0.73 (0.43-1.23) | Â | Â | 0.88 (0.50-1.54) | Â | Â | 0 |
None | 55 | 58% | 51 | 41% | Â | 50 | 54% | Â | 156 | 50% | Â |
Moderate | 37 | 39% | 58 | 47% | Â | 34 | 37% | Â | 129 | 41% | Â |
Extreme | 3 | 3% | 14 | 11% | Â | 9 | 10% | Â | 26 | 8% | Â |
Anxiety or depression (UC: 95; I: 122; SI: 92; All: 309)f | Â | Â | Â | Â | 0.67 (0.39-1.13) | Â | Â | 0.95 (0.54-1.67) | Â | Â | 0 |
None | 53 | 56% | 47 | 39% | Â | 47 | 51% | Â | 147 | 48% | Â |
Moderate | 37 | 39% | 66 | 54% | Â | 37 | 40% | Â | 140 | 45% | Â |
Extreme | 5 | 5% | 9 | 7% | Â | 8 | 9% | Â | 22 | 7% | Â |
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 |