Table 1.
Characteristics of practice sites and participants at baseline by intervention group. Values are number (percentage) unless stated otherwise
| Intervention arm | Usual care arm | ||||
|---|---|---|---|---|---|
| No* | Estimate | No* | Estimate | ||
| Site level characteristics | |||||
| Total No of sites | 17 | — | 13 | — | |
| Mean (SD) practice size | 17 | 20 694 (9714) | 13 | 18 114 (7998) | |
| Mean (SD) No of participants providing consent per site | 17 | 31 (12.05) | 13 | 43 (12.71) | |
| Mean (SD) area level deprivation of practice based on postcode | 17 | 11 (5.02) | 13 | 16 (8.39) | |
| Participant level characteristics | |||||
| Total No of participants | 524 | — | 553 | — | |
| Personal characteristics | |||||
| Mean (SD) age (years); (min-max) | 524 | 68.9 (9.3) (32-94) | 553 | 68.4 (9.2) (30-95) | |
| Ethnicity: | |||||
| White | 522 | 513 (98.3) | 550 | 542 (98.6) | |
| Black, Asian, mixed, or other | 8 (1.5) | 5 (0.9) | |||
| Disclosure declined | 1 (0.2) | 3 (0.6) | |||
| Marital status: | |||||
| Single | 517 | 21 (4.1) | 543 | 25 (4.6) | |
| Married or civil partnered | 436 (84.3) | 455 (83.8) | |||
| Divorced | 31 (6.0) | 32 (5.9) | |||
| Widowed | 27 (5.2) | 28 (5.2) | |||
| Disclosure declined | 2 (0.4) | 3 (0.6) | |||
| Index of multiple deprivation fifth: | |||||
| 1st (most deprived) | 506 | 17 (3.4) | 525 | 21 (4.0) | |
| 2nd | 33 (6.5) | 37 (7.0) | |||
| 3rd | 67 (13.2) | 106 (20.2) | |||
| 4th | 141 (27.9) | 136 (25.9) | |||
| 5th (least deprived) | 248 (49.0) | 225 (42.9) | |||
| Median (IQR) index of multiple deprivation score | 8.80 (5.75-13.71) | 9.89 (6.21-15.45) | |||
| Clinical characteristics | |||||
| Mean (SD) height (cm) (min-max) | 518 | 176.72 (6.77) (152.40-198.12) | 550 | 176.93 (7.41) (157.48-208.28) | |
| Mean (SD) weight (kg) (min-max) | 510 | 83.36 (14.45) (55.02-152.41) | 549 | 83.89 (14.29) (53.98-136.98) | |
| Mean (SD) body mass index (min-max) | 508 | 26.71 (4.40) (18.91-52.31) | 549 | 26.76 (4.00) (17.57-42.18) | |
| No of comorbidities: | |||||
| 0 | 478 | 151 (31.6) | 544 | 171 (31.4) | |
| 1 | 160 (33.5) | 197 (36.2) | |||
| >1 | 167 (34.9) | 176 (32.3) | |||
| Test results in 6 months pre-baseline: | |||||
| Urine analysis: abnormal | 79 | 1 (1.3) | 52 | 2 (3.9) | |
| Kidney function: eGFR (mL/min/1.73m2) | 170 | — | 215 | — | |
| eGFR measures: | |||||
| Mean (SD) eGFR | 170 | 73.5 (15.7) | 215 | 74.6 (13.2) | |
| Median (IQR) eGFR | 76.5 (65-87) | 75 (66-87) | |||
| Min-max eGFR | 28-98 | 36-100 | |||
| CKD stages based on recent eGFR (mL/min/1.73m2): | |||||
| ≥90: normal | 170 | 28 (16.5) | 215 | 33 (15.4) | |
| 90-60: stages G1-G2 | 114 (67.1) | 154 (71.6) | |||
| 30-59: stage G3 | 27 (15.9) | 28 (13.0) | |||
| <30: stages G4-G5 | 1 (0.6) | 0 (0) | |||
| No of GP consultations in 12 months before baseline: | |||||
| Mean (SD) | 478 | 4.4 (3.7) | 544 | 4.8 (5.0) | |
| Median (IQR) | 4 (2-6) | 4 (2-6) | |||
| Min-max | 0-23 | 0-58 | |||
| Referrals to urology in 12 months pre-baseline: | |||||
| 0 | 478 | 464 (97.1) | 544 | 525 (96.5) | |
| 1 | 14 (2.9) | 19 (3.5) | |||
| >1 | 0 | 0 | |||
| Patient reported symptoms and quality of life | |||||
| Mean (SD) IPSS (min-max): | |||||
| Incomplete emptying | 512 | 1.7 (1.5) (0-5) | 549 | 1.9 (1.5) (0-5) | |
| Frequency | 514 | 2.7 (1.3) (0-5) | 551 | 2.9 (1.4) (0-5) | |
| Intermittency | 514 | 1.9 (1.6) (0-5) | 549 | 2.0 (1.7) (0-5) | |
| Urgency | 513 | 2.1 (1.6) (0-5) | 549 | 2.3 (1.7) (0-5) | |
| Weak stream | 510 | 1.9 (1.5) (0-5) | 549 | 2.0 (1.7) (0-5) | |
| Straining | 513 | 0.8 (1.2) (0-5) | 548 | 1.0 (1.3) (0-5) | |
| Nocturia | 516 | 2.6 (1.4) (0-5) | 551 | 2.4 (1.2) (0-5) | |
| Mean (SD) total IPSS (min-max) | 501 | 13.6 (5.8) (1-33) | 541 | 14.6 (6.6) (2-34) | |
| Symptom severity by IPSS: | |||||
| ≤7: mild | 501 | 76 (15.2) | 541 | 74 (13.7) | |
| 8-19; moderate | 342 (68.3) | 338 (62.5) | |||
| ≥20: severe | 83 (16.6) | 129 (23.8) | |||
| Mean (SD) IPSS quality of life score† (min-max) | 516 | 3.5 (1.2) (0-6) | 551 | 3.6 (1.1) (0-6) | |
| Mean (SD) ICIQ-UI-SF total score (min-max) | 513 | 3.6 (3.6) (0-14) | 542 | 3.9 (3.7) (0-15) | |
| ICIQ-UI-SF urine leakage‡: | |||||
| Never | 523 | 185 (35.4) | 553 | 161 (29.2) | |
| Before getting to the toilet | 205 (39.2) | 237 (42.9) | |||
| When coughing/sneezing | 24 (4.6) | 24 (4.4) | |||
| When asleep | 12 (2.3) | 15 (2.7) | |||
| During physical activity | 23 (4.4) | 27 (4.9) | |||
| After urinating/when dressed | 175 (33.5) | 205 (37.1) | |||
| No obvious reason | 36 (6.9) | 42 (7.6) | |||
| All the time | 1 (0.2) | 1 (0.2) | |||
| Mean (SD) B-IPQ total score (min-max) | 440 | 38.7 (11.0) (1-75) | 478 | 39.4 (10.4) (6-72) | |
| Bladder diary§: | |||||
| Incontinence | 502 | 100 (19.9) | — | — | |
| Urgency | 507 | 364 (71.8) | — | — | |
| Nocturia¶ | 261 | 222 (85.1) | — | — | |
B-IPQ=Brief Illness Perception Questionnaire; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; IQR=interquartile range; ICIQ-UI-SF=International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form; IPSS=International Prostate Symptom Score; SD=standard deviation.
Number providing non-missing data at baseline.
Question asked: “If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?”
Question asked: “When does urine leak?”
Bladder diary completed as part of initial assessment in intervention arm only.
For description purposes at baseline, nocturia is defined as waking to urinate at least once on two nights or to urinate twice or more. When data on waking or sleeping were not provided by participants, the variable was set to missing.