This chapter describes how the participants were identified from 63 hospitals across the UK and reports the baseline characteristics up to the point of trial entry. The subsequent findings are described in Chapter 4 (Clinical results), Chapter 5 (Health Economic evaluation), Chapter 6 (Qualitative study) and Chapter 7 (Urodynamics quality assurance).
Between November 2017 and January 2021, 3066 potentially eligible women were screened, 1511 (49.3%) were confirmed eligible, of whom 1103 (73.0%) gave their consent and were randomised: 553 to receive urodynamics plus CCA and 550 to receive CCA only (Figure 2). There was a pause in recruitment between March 2020 and August 2020 due to the COVID-19 pandemic. The majority of participants were randomised prior to the pause, with only 81 participants (7.3%) randomised after August 2020: 43 to receive urodynamics plus CCA and 38 to receive CCA only.
FIGURE 2 Flow of participants to the point of randomisation. (Figure not reproduced here; see the original article.)
Following randomisation, four participants were considered ineligible, recorded as post-randomisation exclusions and not included in any trial analyses (see Figure 2). This included one participant in the urodynamics plus CCA arm who was randomised after the recruitment pause. Therefore, 550 participants in the urodynamics plus CCA arm and 549 participants in the CCA only arm were included in the trial.
Study recruitment
The trial design and recruitment methodology have been reported previously1 (see Chapter 2). Women with OAB or urgency-predominant MUI were identified at outpatient clinics or from urodynamic/outpatient waiting lists. Those meeting the eligibility criteria were invited to participate. The sites who participated in the FUTURE trial, including numbers recruited by site, are described in Appendix 1 (see Table 28). The highest recruiting site was NHSG, with 92 randomised participants. This accounted for 8.3% of the total number randomised across the study, therefore no one site dominated recruitment. The recruitment rate is illustrated in Figure 3.
FIGURE 3 Recruitment to the trial over time. (Figure not reproduced here; see the original article.)
Non-recruited participants
Of the 3066 participants approached, 1963 were either ineligible (n = 1555, 50.7%) or declined participation (n = 408; 13.3%; see Appendix 1, Table 29). Reasons for ineligibility included predominant SUI symptoms (n = 318; 20.5%), other clinical diagnosis not OAB or urgency-predominant MUI (n = 227; 14.6%), had not failed conservative management and/or two pharmacological treatments (n = 181; 11.6%), previous urodynamics in the last 12 months (n = 166; 10.7%), previous treatment with BoNT-A or SNM for UI (n = 140; 9.0%), neurogenic bladder (n = 93; 6.0%) and bladder pain syndrome (n = 78; 5.0%) (see Appendix 1, Table 30).
The most common reasons for participants declining to take part was an unwillingness to accept randomisation (n = 90; 22.1%), a preference for a particular clinical pathway (n = 66; 16.2%) and personal reasons (n = 49; 12.0%). One hundred and twenty participants (29.4%) did not provide a reason for declining trial participation (see Appendix 1, Table 30).
Randomised participants: baseline characteristics
The baseline characteristics for the 1099 participants who agreed to participate in the FUTURE trial and who were truly eligible to take part are described in Tables 2 and 3.
| UrodynamicsN = 550 | CCA onlyN = 549 | |
|---|---|---|
| Age | 59.3 (14.0); (N = 550) | 59.8 (13.1); (N = 549) |
| BMI | 30.6 (6.3); (N = 540) | 30.9 (7.1); (N = 536) |
| BMI > 30 | 263 (47.8%) | 257 (46.8%) |
| BMI > 35 | 120 (21.8%) | 141 (25.7%) |
| Diagnosis | ||
| OAB | 363 (66.0%) | 365 (66.5%) |
| MUI | 187 (34.0%) | 184 (33.5%) |
| Number of deliveries | ||
| 0 | 61 (11.1%) | 63 (11.5%) |
| 1 | 71 (12.9%) | 86 (15.7%) |
| 2 | 235 (42.7%) | 204 (37.2%) |
| 3 or more | 174 (31.6%) | 190 (34.6%) |
| Missing | 9 (1.6%) | 6 (1.1%) |
| Lab-confirmed UTI in last 12 months | ||
| 0 | 426 (77.5%) | 402 (73.2%) |
| 1 | 64 (11.6%) | 69 (12.6%) |
| 2 | 30 (5.5%) | 40 (7.3%) |
| 3 or more | 30 (5.5%) | 36 (6.6%) |
| Missing | 2 (0.4%) | |
| Courses of antibiotics for UTI in last 12 months | ||
| 0 | 386 (70.2%) | 366 (66.7%) |
| 1 | 60 (10.9%) | 80 (14.6%) |
| 2 | 45 (8.2%) | 47 (8.6%) |
| 3 or more | 57 (10.4%) | 53 (9.7%) |
| Missing | 2 (0.4%) | 3 (0.5%) |
| Received CISC training | 15 (2.7%) | 23 (4.2%) |
| Previous surgery | ||
| SUI only | 67 (12.2%) | 74 (13.5%) |
| Prolapse only | 72 (13.1%) | 63 (11.5%) |
| Prolapse and SUI surgery | 21 (3.8%) | 25 (4.6%) |
| Current medication | ||
| Anticholinergic drug | 200 (36.4%) | 202 (36.8%) |
| Betmiga | 240 (43.6%) | 226 (41.2%) |
| Low-dose prophylactic antibiotics | 19 (3.5%) | 22 (4.0%) |
| Previously tried betmiga | 410 (74.5%) | 388 (70.7%) |
| Previous conservative treatment | ||
| Bladder training | 377 (68.5%) | 383 (69.8%) |
| PFMT | 448 (81.5%) | 474 (86.3%) |
| Percutaneous tibial nerve stimulation | 28 (5.1%) | 26 (4.7%) |
| Acupuncture | 17 (3.1%) | 15 (2.7%) |
| Biofeedback | 26 (4.7%) | 19 (3.5%) |
| Baseline bladder diary summary | 406 (73.8%) | 372 (67.8%) |
| Daytime frequency | 7.9 (3.8); (N = 396) | 7.9 (3.2); (N = 367) |
| Daytime frequency > 7 per day | 208/396 (52.5%) | 180/367 (49.0%) |
| Nocturia | 1.9 (1.5); (N = 394) | 2.0 (1.4); (N = 366) |
| Nocturnal frequency > 2 per day | 133/394 (33.8%) | 141/366 (38.5%) |
| Number mild urgency episodes per 24 hours | 1.3 (1.8); (N = 351) | 1.0 (1.4); (N = 331) |
| Number moderate urgency episodes per 24 hours | 3.3 (3.1); (N = 351) | 3.1 (2.8); (N = 331) |
| Number severe urgency episodes per 24 hours | 2.8 (2.8); (N = 353) | 3.1 (3.4); (N = 333) |
| UI episodes per 24 hours | 4.3 (3.7); (N = 405) | 4.4 (3.9); (N = 370) |
| UUI episodes per 24 hours | 2.9 (3.3); (N = 405) | 3.0 (3.2); (N = 370) |
| SUI episodes per 24 hours | 0.2 (0.6); (N = 405) | 0.2 (0.7); (N = 370) |
| UrodynamicsN = 550 | CCA onlyN = 549 | |
|---|---|---|
| How much do urinary symptoms interfere with your everyday life? | 8.0 (2.1); (N = 530) | 7.9 (2.0); (N = 533) |
| ICIQ-FLUTS filling score | 8.4 (2.7); (N = 527) | 8.4 (2.8); (N = 530) |
| ICIQ-FLUTS voiding score | 2.6 (2.6); (N = 530) | 2.5 (2.3); (N = 536) |
| ICIQ-FLUTS incontinence score | 10.5 (4.6); (N = 528) | 10.8 (4.3); (N = 527) |
| ICIQ-OAB score | 10.0 (2.7); (N = 531) | 10.2 (2.7); (N = 533) |
| ICIQ-LUTS HRQoL score | 51.8 (12.1); (N = 497) | 52.3 (12.8); (N = 497) |
| EQ-5D-5L | 0.653 (0.290); (N = 531) | 0.674 (0.293); (N = 529) |
| UPS | ||
| None | 2 (0.4%) | 5 (0.9%) |
| Mild | 10 (1.8%) | 12 (2.2%) |
| Moderate | 156 (28.4%) | 151 (27.5%) |
| Severe | 353 (64.2%) | 345 (62.8%) |
| Missing | 29 (5.3%) | 36 (6.6%) |
Participant characteristics
The two randomised groups were comparable at baseline (see Table 2). The mean age of participants was between 59 and 60 years. The BMI was similar in both groups at slightly ˃ 30 kg/m2. Almost 50% of women had BMI > 30. In both groups approximately two-thirds of the participants were diagnosed as predominantly OAB and one-third with urgency-predominant MUI.
Lab-confirmed UTIs and courses of antibiotics for UTIs were slightly more common in the women randomised to urodynamics plus CCA. Previous prolapse and SUI surgery rates were similar across both groups, with slightly ˂ 30% of participants previously receiving surgery. PFMT was the most common previous conservative treatment. Current and previous OAB medical treatment use was similar between the two randomised groups.
Health-related quality of life scores at baseline
The baseline questionnaire scores show the two groups as similar (see Table 3). The mean EQ-5D-5L is 0.02 higher for those randomised to CCA only (the higher scores indicate better HRQoL). However, as the baseline scores in both groups range from very poor HRQoL to excellent HRQoL, there is a large amount of uncertainty, and this difference is relatively small. In comparison, the mean EQ-5D-5L score for females in the age range 60–64 is 0.776 (0.769, 0.797) and the FUTURE trial population is therefore more than 0.1 lower.74
The mean ICIQ-LUTS HRQoL scores are close to the midpoint of the range in both randomised groups and, overall, scores are seen on close to the full range of the scale (see Table 3).
On the ICIQ-FLUTS filling score, ICIQ-FLUTS incontinence score and ICIQ-OAB score, some women were reporting the maximum impact. The everyday-life interference also shows women’s symptoms as having a major impact on their lives (see Table 3). Over 90% of participants perceive their urgency as either moderate or severe on the UPS (see Table 3).
Baseline 3-day bladder diary
The baseline bladder diaries were completed by 778 participants [406 participants (73.8%) in the urodynamic arm and 372 participants in the CCA arm (67.8%)]. Daytime frequency and nocturia were very similar in both groups at a mean of 7.9 [standard deviation (SD) 3.8] compared to 7.9 (SD 3.2) and a mean of 1.9 (SD 1.5) compared to 2.0 (SD 1.4) respectively. Of the CCA only participants 38.5% had nocturia ˃ 2 voiding episodes per day compared to 33.8% of the urodynamics plus CCA participants, while a higher percentage of urodynamics participants (52.5% compared to 49.0%) had a daytime frequency ˃ 7 voiding episodes per day.
Urgency was slightly higher in the CCA only group, with participants reporting a mean of 1.0 (SD 1.4) mild episodes and 3.1 (SD 3.4) severe episodes, compared to 1.3 (SD 1.8) and 2.8 (SD 2.8) respectively in the urodynamics group plus CCA. There were no differences in the number of UI episodes between participants in both groups.