Background
Methods
Aim
Design
Patient and public engagement
Setting
Participants
Randomisation
Intervention
Outcome measures
Data analysis
Nested qualitative study
Results
Participants characteristics
Variable | Overall | Intervention group | Control group | p-value | |||
---|---|---|---|---|---|---|---|
n | % | n | % | n | % | ||
Total | 49 | 24 | 25 | ||||
Age (Mean, SD) | 69.7 | 9.1 | 69.5 | 8.9 | 69.6 | 9.6 | 0.994 |
Ethnicity | 0.157 | ||||||
White British | 38 | 77.6% | 16 | 66.7% | 22 | 88.0% | |
Asian Indian | 9 | 18.4% | 7 | 29.2% | 2 | 8.0% | |
Mixed White and Black African | 2 | 4.1% | 1 | 4.2% | 1 | 4.0% | |
Education | 0.486 | ||||||
Primary | 4 | 8.2% | 3 | 12.5% | 1 | 4.0% | |
Secondary | 16 | 32.7% | 9 | 37.5% | 7 | 28.0% | |
Further | 14 | 28.6% | 5 | 20.8% | 9 | 36.0% | |
Higher | 15 | 30.6% | 7 | 29.2% | 8 | 32.0% | |
Religion | 0.108 | ||||||
No religion | 9 | 18.4% | 5 | 20.8% | 4 | 16.0% | |
Christian | 31 | 63.3% | 12 | 50.0% | 19 | 76.0% | |
Hindu | 9 | 18.4% | 7 | 29.2% | 2 | 8.0% | |
Marital status | 0.365 | ||||||
Single | 6 | 12.2% | 3 | 12.5% | 3 | 12.0% | |
Married | 27 | 55.1% | 15 | 62.5% | 12 | 48.0% | |
Separated | 1 | 2.0% | 0 | 0.0% | 1 | 4.0% | |
Divorced | 3 | 6.1% | 0 | 0.0% | 3 | 12.0% | |
Widowed | 12 | 24.5% | 6 | 25.0% | 6 | 24.0% | |
Employment | 0.573 | ||||||
Full time employed | 3 | 6.1% | 1 | 4.2% | 2 | 8.0% | |
Part time employed | 5 | 10.2% | 3 | 12.5% | 2 | 8.0% | |
Self employed | 1 | 2.0% | 0 | 0.0% | 1 | 4.0% | |
Not in paid employment | 2 | 4.1% | 1 | 4.2% | 1 | 4.0% | |
Unemployed-looking for work | 1 | 2.0% | 0 | 0.0% | 1 | 4.0% | |
Retired | 35 | 71.4% | 19 | 79.2% | 16 | 64.0% | |
Unable to work | 2 | 4.1% | 0 | 0.0% | 2 | 8.0% | |
Children | 0.421 | ||||||
None | 11 | 22.4% | 5 | 20.8% | 6 | 24.0% | |
1 | 3 | 6.1% | 1 | 4.2% | 2 | 8.0% | |
2 | 18 | 36.7% | 9 | 37.5% | 9 | 36.0% | |
3 | 11 | 22.4% | 4 | 16.7% | 7 | 28.0% | |
UI type | 0.672 | ||||||
Stress UI | 14 | 28.6% | 8 | 33.3% | 6 | 24.0% | |
Urge UI | 17 | 34.7% | 7 | 29.2% | 10 | 40.0% | |
Mixed UI | 18 | 36.7% | 9 | 37.5% | 9 | 36.0% | |
Frequency of UI (average per day) | 0.070 | ||||||
None | 16 | 32.7% | 12 | 50.0% | 4 | 16.0% | |
1 | 8 | 16.3% | 3 | 12.5% | 5 | 20.0% | |
2 | 5 | 10.2% | 1 | 4.2% | 4 | 16.0% | |
3 | 9 | 18.4% | 5 | 20.8% | 4 | 16.0% | |
4+ | 11 | 22.4% | 3 | 12.5% | 8 | 32.0% |
Outcome measures
Variable | Dimensions | Intervention group | Control group | p-value | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | Median | IQR | Mean | SD | n | % | Median | IQR | Mean | SD | |||
EQ-5D-5L | Mobility | 0.675 | ||||||||||||
No/slight problem | 18 | 75.0% | 20 | 80.0% | ||||||||||
Moderate/Severe/extreme problem | 6 | 25.0% | 5 | 20.0% | ||||||||||
Selfcare | 0.527 | |||||||||||||
No/slight problem | 22 | 91.7% | 24 | 96.0% | ||||||||||
Moderate/Severe/extreme problem | 2 | 8.3% | 1 | 4.0% | ||||||||||
Usual activities | 0.662 | |||||||||||||
No/slight problem | 19 | 79.2% | 21 | 84.0% | ||||||||||
Moderate/Severe/extreme problem | 5 | 20.8% | 4 | 16.0% | ||||||||||
Pain & discomfort | 0.315 | |||||||||||||
No/slight problem | 14 | 58.3% | 18 | 72.0% | ||||||||||
Moderate/Severe/extreme problem | 10 | 41.7% | 7 | 28.0% | ||||||||||
Anxiety & depression | 0.524 | |||||||||||||
No/slight problem | 20 | 83.3% | 19 | 76.0% | ||||||||||
Moderate/Severe/extreme problem | 4 | 16.7% | 6 | 24.0% | ||||||||||
Index | 24 | 0.90 | 0.23 | 0.82 | 0.17 | 25 | 0.83 | 0.14 | 0.79 | 0.19 | 0.643 | |||
VAS | 24 | 77.50 | 27.50 | 71.67 | 18.04 | 25 | 70.00 | 25.00 | 64.40 | 25.59 | 0.258 | |||
KHQ | Part I | |||||||||||||
General health perception (0-100) | 24 | 25.00 | 25.00 | 33.33 | 21.70 | 25 | 25.00 | 25.00 | 32.00 | 15.34 | 0.804 | |||
Incontinence impact (0-100) | 24 | 33.33 | 33.33 | 45.83 | 23.70 | 24 | 66.67 | 33.33 | 56.94 | 20.80 | 0.091 | |||
Part II | ||||||||||||||
Role limitations (0-100) | 24 | 16.67 | 33.33 | 20.14 | 22.51 | 25 | 33.33 | 33.33 | 33.33 | 24.06 | 0.054 | |||
Physical limitations (0-100) | 24 | 16.67 | 41.67 | 22.92 | 22.42 | 25 | 33.33 | 33.33 | 30.67 | 20.79 | 0.216 | |||
Social limitations (0-100) | 24 | 0.00 | 13.89 | 9.03 | 13.19 | 25 | 0.00 | 22.22 | 16.44 | 24.40 | 0.195 | |||
Personal relationships (0-100) | 15 | 0.00 | 0.00 | 5.56 | 12.06 | 14 | 0.00 | 0.00 | 11.90 | 25.68 | 0.396 | |||
Emotions (0-100) | 24 | 11.11 | 22.22 | 16.67 | 19.93 | 24 | 11.11 | 11.11 | 17.59 | 14.98 | 0.856 | |||
Sleep/energy (0-100) | 24 | 33.33 | 41.67 | 37.50 | 28.34 | 25 | 50.00 | 50.00 | 47.33 | 32.16 | 0.263 | |||
Severity measures (0-100) | 24 | 33.33 | 29.17 | 34.03 | 22.10 | 25 | 41.67 | 33.33 | 48.67 | 22.91 | 0.028 | |||
Part III | ||||||||||||||
Symptom severity scale (0-30) | 24 | 7.50 | 5.50 | 8.00 | 4.39 | 25 | 10.00 | 3.00 | 9.92 | 4.06 | 0.119 | |||
ICIQ-UI SF | Scale (0-21) | 24 | 8.00 | 6.50 | 8.63 | 4.03 | 25 | 9.00 | 6.00 | 9.68 | 4.19 | 0.374 | ||
GSE-UI | Scale (0-120) | 24 | 84.50 | 33.50 | 84.96 | 18.89 | 25 | 55.00 | 23.00 | 57.76 | 23.55 | 0.000 | ||
HADS | Anxiety scale (0-21) | 24 | 6.50 | 6.50 | 7.13 | 5.12 | 25 | 7.00 | 5.00 | 7.56 | 4.56 | 0.755 | ||
Normal | 13 | 54.2% | 13 | 52.0% | 0.868 | |||||||||
Mild | 7 | 29.2% | 6 | 24.0% | ||||||||||
Moderate | 2 | 8.3% | 4 | 16.0% | ||||||||||
Severe | 2 | 8.3% | 2 | 8.0% | ||||||||||
Depression scale (0-21) | 24 | 3.00 | 3.50 | 3.67 | 3.29 | 25 | 3.00 | 4.00 | 3.88 | 4.02 | 0.840 | |||
Normal | 20 | 83.3% | 23 | 92.0% | 0.318 | |||||||||
Mild | 2 | 8.3% | 0 | 0.0% | ||||||||||
Moderate | 2 | 8.3% | 1 | 4.0% | ||||||||||
Severe | 0 | 0 |
Variable | Dimensions | Intervention group | Control group | p-value | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | Median | IQR | Mean | SD | n | % | Median | IQR | Mean | SD | |||
EQ-5D-5L | Mobility | 0.478 | ||||||||||||
No/slight problem | 21 | 87.5% | 20 | 80.0% | ||||||||||
Moderate/Severe/extreme problem | 3 | 12.5% | 5 | 20.0% | ||||||||||
Selfcare | 0.322 | |||||||||||||
No/slight problem | 24 | 100.0% | 24 | 96.0% | ||||||||||
Moderate/Severe/extreme problem | 0 | 0.0% | 1 | 4.0% | ||||||||||
Usual activities | 0.950 | |||||||||||||
No/slight problem | 20 | 83.3% | 21 | 84.0% | ||||||||||
Moderate/Severe/extreme problem | 4 | 16.7% | 4 | 16.0% | ||||||||||
Pain & discomfort | 0.682 | |||||||||||||
No/slight problem | 17 | 70.8% | 19 | 76.0% | ||||||||||
Moderate/Severe/extreme problem | 7 | 29.2% | 6 | 24.0% | ||||||||||
Anxiety & depression | 0.957 | |||||||||||||
No/slight problem | 21 | 87.5% | 22 | 88.0% | ||||||||||
Moderate/Severe/extreme problem | 3 | 12.5% | 3 | 12.0% | ||||||||||
Index | 24 | 0.92 | 0.26 | 0.86 | 0.16 | 25 | 0.88 | 0.16 | 0.83 | 0.19 | 0.471 | |||
VAS | 24 | 80.00 | 20.00 | 78.54 | 17.60 | 25 | 75.00 | 15.00 | 73.00 | 14.93 | 0.240 | |||
KHQ | Part I | |||||||||||||
General health perception (0-100) | 24 | 25.00 | 12.50 | 30.21 | 23.29 | 25 | 25.00 | 25.00 | 31.00 | 20.77 | 0.900 | |||
Incontinence impact (0-100) | 24 | 33.33 | 33.33 | 45.83 | 21.56 | 25 | 33.33 | 33.33 | 49.33 | 25.68 | 0.609 | |||
Part II | ||||||||||||||
Role limitations (0-100) | 24 | 16.67 | 33.33 | 20.14 | 23.04 | 25 | 33.33 | 33.33 | 30.67 | 23.90 | 0.123 | |||
Physical limitations (0-100) | 24 | 16.67 | 33.33 | 22.92 | 22.42 | 25 | 33.33 | 33.33 | 32.67 | 24.76 | 0.156 | |||
Social limitations (0-100) | 24 | 0.00 | 5.56 | 5.56 | 10.87 | 25 | 0.00 | 11.11 | 8.22 | 20.98 | 0.581 | |||
Personal relationships (0-100) | 16 | 0.00 | 0.00 | 0.00 | 0.00 | 16 | 0.00 | 0.00 | 5.21 | 11.74 | 0.086 | |||
Emotions (0-100) | 24 | 11.11 | 22.22 | 12.50 | 14.40 | 25 | 11.11 | 22.22 | 16.44 | 20.06 | 0.435 | |||
Sleep/energy (0-100) | 24 | 16.67 | 33.33 | 27.08 | 31.01 | 25 | 33.33 | 33.33 | 37.33 | 31.28 | 0.255 | |||
Severity measures (0-100) | 24 | 25.00 | 16.67 | 26.39 | 17.66 | 25 | 33.33 | 25.00 | 37.33 | 20.99 | 0.055 | |||
Part III | ||||||||||||||
Symptom severity scale (0-30) | 24 | 6.00 | 4.00 | 6.38 | 2.93 | 25 | 10.00 | 4.00 | 9.04 | 3.51 | 0.006 | |||
ICIQ-UI SF | Scale (0-21) | 24 | 4.50 | 4.00 | 5.38 | 2.83 | 25 | 9.00 | 5.00 | 7.76 | 4.08 | 0.022 | ||
GSE-UI | Scale (0-120) | 24 | 94.50 | 31.00 | 89.13 | 23.86 | 25 | 67.00 | 34.00 | 69.08 | 25.46 | 0.007 | ||
HADS | Anxiety scale (0-21) | 24 | 5.00 | 6.00 | 5.13 | 4.59 | 25 | 7.00 | 5.00 | 7.80 | 4.65 | 0.049 | ||
Normal | 19 | 79.2% | 16 | 64.0% | 0.593 | |||||||||
Mild | 2 | 8.3% | 4 | 16.0% | ||||||||||
Moderate | 2 | 8.3% | 2 | 8.0% | ||||||||||
Severe | 1 | 4.2% | 3 | 12.0% | ||||||||||
Depression scale (0-21) | 24 | 2.00 | 3.50 | 3.08 | 3.28 | 25 | 3.00 | 3.00 | 3.44 | 3.92 | 0.732 | |||
Normal | 21 | 87.5% | 22 | 88.0% | 0.720 | |||||||||
Mild | 2 | 8.3% | 1 | 4.0% | ||||||||||
Moderate | 1 | 4.2% | 1 | 4.0% | ||||||||||
Severe | 0 | 0.0% | 0 |
Variable | Dimensions | Baseline differencea | Follow-up differencea | Treatment effectc | ||||||
---|---|---|---|---|---|---|---|---|---|---|
ORb/Coef. | SE | p-value | ORb/Coef. | SE | p-value | ORb/Coef. | SE | p-value | ||
EQ-5D-5L | Mobility | |||||||||
No/slight problem | ||||||||||
Moderate/Severe/extreme problem | 1.33 | 0.92 | 0.675 | 0.57 | 0.45 | 0.481 | 0.32 | 0.33 | 0.267 | |
Selfcare | ||||||||||
No/slight problem | ||||||||||
Moderate/Severe/extreme problem | ||||||||||
Usual activities | ||||||||||
No/slight problem | ||||||||||
Moderate/Severe/extreme problem | 1.38 | 1.02 | 0.663 | 1.05 | 0.81 | 0.950 | 0.74 | 0.77 | 0.774 | |
Pain & discomfort | ||||||||||
No/slight problem | ||||||||||
Moderate/Severe/extreme problem | 1.84 | 1.12 | 0.317 | 1.30 | 0.85 | 0.683 | 0.63 | 0.62 | 0.637 | |
Anxiety & depression | ||||||||||
No/slight problem | ||||||||||
Moderate/Severe/extreme problem | 0.63 | 0.46 | 0.526 | 1.05 | 0.91 | 0.957 | 1.24 | 1.14 | 0.811 | |
Index | 0.02 | 0.05 | 0.643 | 0.04 | 0.05 | 0.471 | 0.02 | 0.03 | 0.540 | |
VAS | 7.27 | 6.35 | 0.258 | 5.54 | 4.66 | 0.240 | 3.82 | 4.51 | 0.402 | |
KHQ | Part I | |||||||||
General health perception (0-100) | 1.33 | 5.35 | 0.804 | -0.79 | 6.30 | 0.900 | -1.63 | 5.38 | 0.763 | |
Incontinence impact (0-100) | -11.11 | 6.44 | 0.091 | -3.50 | 6.79 | 0.609 | 3.07 | 6.26 | 0.626 | |
Part II | ||||||||||
Role limitations (0-100) | -13.19 | 6.66 | 0.054 | -10.53 | 6.71 | 0.123 | -1.06 | 4.96 | 0.831 | |
Physical limitations (0-100) | -7.75 | 6.17 | 0.216 | -9.75 | 6.76 | 0.156 | -3.82 | 4.96 | 0.446 | |
Social limitations (0-100) | -7.42 | 5.64 | 0.195 | -2.67 | 4.80 | 0.581 | 1.66 | 3.61 | 0.648 | |
Personal relationships (0-100) | -6.35 | 7.37 | 0.396 | -5.21 | 2.93 | 0.086 | -3.89 | 2.19 | 0.088 | |
Emotions (0-100) | -0.93 | 5.09 | 0.856 | -3.94 | 5.01 | 0.435 | -3.44 | 3.24 | 0.294 | |
Sleep/energy (0-100) | -9.83 | 8.67 | 0.263 | -10.25 | 8.90 | 0.255 | -3.68 | 6.92 | 0.598 | |
Severity measures (0-100) | -14.64 | 6.44 | 0.028 | -10.94 | 5.55 | 0.055 | -1.36 | 3.86 | 0.725 | |
Part III | ||||||||||
Symptom severity scale (0-30) | -1.92 | 1.21 | 0.119 | -2.67 | 0.93 | 0.006 | -1.77 | 0.76 | 0.025 | |
ICIQ-UI SF | Scale (0-21) | -1.06 | 1.18 | 0.374 | -2.39 | 1.01 | 0.022 | -1.87 | 0.84 | 0.031 |
GSE-UI | Scale (0-120) | 27.20 | 6.11 | 0.000 | 20.05 | 7.05 | 0.007 | -4.90 | 5.16 | 0.348 |
HADS | Anxiety scale (0-21) | -0.44 | 1.38 | 0.755 | -2.68 | 1.32 | 0.049 | -2.31 | 0.66 | 0.001 |
Normal | ||||||||||
Ill | 0.92 | 0.53 | 0.879 | 0.47 | 0.31 | 0.245 | 0.34 | 0.28 | 0.188 | |
Depression scale (0-21) | -0.21 | 1.05 | 0.840 | -0.36 | 1.03 | 0.732 | -0.17 | 0.46 | 0.715 | |
Normal | ||||||||||
Ill | 2.30 | 2.11 | 0.364 | 1.05 | 0.91 | 0.957 | 0.44 | 0.54 | 0.505 |
Mean change (SD) | PGI-I | Spearman's correlation | ||||||
---|---|---|---|---|---|---|---|---|
Very much worse | Much worse | A little worse | No change | A little better | Much better | Very much better | ||
0 (0%) | 0 (0%) | 4 (16.7) | 3 (12.5) | 9 (37.5) | 7 (29.2) | 1 (4.2) | ||
EQ-5D-5L | ||||||||
Index | NA | NA | 0.03 (0.10) | 0.08 (0.01) | 0.05 (0.09) | 0.05 (0.14) | 0.00 (.) | -0.05 |
VAS | NA | NA | 2.50 (16.58) | 8.33 (23.63) | 13.89 (18.33) | 2.86 (14.39) | -15.00 (.) | -0.04 |
KHQ | ||||||||
Part I | ||||||||
General health perception (0-100) | NA | NA | 12.50 (43.30) | 8.33 (14.43) | -8.33 (17.68) | -14.29 (13.36) | 25.00 (.) | -0.25 |
Incontinence impact (0-100) | NA | NA | -8.33 (16.67) | 0.00 (33.33) | 7.41 (27.78) | -4.76 (12.60) | 0.00 (.) | 0.05 |
Part II | ||||||||
Role limitations (0-100) | NA | NA | -8.33 (9.62) | 5.56 (9.62) | -0.00 (18.63) | 2.38 (17.82) | 0.00 (.) | 0.15 |
Physical limitations (0-100) | NA | NA | 8.33 (28.87) | 0.00 (16.67) | 1.85 (15.47) | -4.76 (8.13) | -16.67 (.) | -0.19 |
Social limitations (0-100) | NA | NA | -5.56 (6.42) | 0.00 (0.00) | -0.62 (14.28) | -7.94 (12.36) | 0.00 (.) | -0.05 |
Personal relationships (0-100) | NA | NA | -16.67 (16.67) | 0.00 (.) | 0.00 (0.00) | -6.67 (14.91) | 0.00 (.) | 0.29 |
Emotions (0-100) | NA | NA | -11.11 (20.29) | 0.00 (0.00) | -3.70 (9.62) | -6.35 (8.74) | 22.22 (.) | 0.08 |
Sleep/energy (0-100) | NA | NA | -4.17 (20.97) | -22.22 (9.62) | -7.41 (23.73) | -21.43 (20.89) | 50.00 (.) | -0.02 |
Severity measures (0-100) | NA | NA | -12.50 (4.81) | -22.22 (17.35) | -3.70 (10.30) | -4.76 (13.49) | 0.00 (.) | 0.38* |
Part III | ||||||||
Symptom severity scale (0-30) | NA | NA | -1.25 (6.50) | 0.00 (4.36) | -1.89 (3.92) | -2.43 (3.78) | 0.00 (.) | -0.13 |
ICIQ-UI SF | ||||||||
Scale (0-21) | NA | NA | -2.75 (2.22) | -1.33 (4.51) | -3.89 (3.66) | -3.86 (4.34) | -1.00 (.) | -0.02 |
GSE-UI | ||||||||
Scale (0-120) | NA | NA | -15.00 (17.03) | 0.67 (11.02) | 8.78 (9.87) | 10.71 (15.64) | 4.00 (.) | 0.43** |
HADS | ||||||||
Anxiety scale (0-21) | NA | NA | -1.75 (0.96) | -0.67 (1.53) | -1.11 (1.96) | -4.14 (3.34) | 0.00 (.) | -0.22 |
Depression scale (0-21) | NA | NA | -1.00 (1.63) | 0.33 (0.58) | -0.56 (1.88) | -0.86 (2.12) | 0.00 (.) | -0.02 |
Qualitative findings
Raising awareness and gaining/refreshing knowledge
“Yeah, I found the information on how to do the pelvic floor muscle exercises really good, it describes exactly what you should do and how much you should do..” (W5)
Feeling more confident and motivated to management UI
“…we can do this, at least we know where to contact, we can tell the doctors also but if it happens to somebody you can tell them and they can do this.”(W24)
“I suspect a lot of people would read the book, and think, oh yeah, that’s a really good idea, I ought to be doing that, and then never, ever actually do it.”(W46)
Being a useful and user-friendly package
“The book was very well put together, and very clear, very easy to read, and it was very informative.” (W6)
“I’m still having the occasional accident, but now I’m sort of going oh well, I will get there. It’s not a major setback. But it’s not affecting my life like it used to.” (W5)