Table 2 Progression criteria

Sixty participants recruited within a 7-month recruitment window

• Red: < 60%

• Amber: 60–80%

• Green: > 80%

24/60 (40%)

Percentage of participants randomised to intervention group noncompliant in wearing the shorts (noncompliance — wearing the shorts for less than 6 h/day or total of 42 h/week)

• Red: > 70%

• Amber: 50–70%

• Green: < 50%

9/9 (100%)

Percentage of participants completing primary outcome measure (NPRS) at 24-week follow-up

• Red: < 60%

• Amber: 60–80%

• Green: > 80%

18/24 (75%) of those randomised

18/19 (95%) of those followed up

*Percentage of participants completing secondary outcome measures at 24-week follow-up

• Red < 60%

• Amber: 60–80%

• Green > 80%

Of those randomised

• EQ- 5D- 5L: 18/24 (75%)

• SF- 36: 18/24 (75%)

• PGQ: 18/24 (75%)

• ICIQ: 17/24 (71%)

Of those followed up

• EQ- 5D- 5L: 18/19 (95%)

• SF- 36: 18/19 (95%)

• PGQ: 18/19 (95%)

• ICIQ: 17/19 (89%)

Evidence to suggest efficacy, i.e. that the DEFO holds promise as an effective intervention, demonstrated by an 80% CI that indicates plausibility of the between-group difference in the primary outcome measure being ≥ 1 point, on the NPRS

N/A

• **Worst level in day: − 0.68 [− 2.14, 0.78]

• Average level in day: 0.13 [− 1.07, 1.32]