Table 1 Source and timing of outcome measures to be assessed
Outcome measure | Source | Timing | |||
|---|---|---|---|---|---|
Baselinea | Post-randomisation (months) | ||||
3 | 6 | 15 | |||
Treatment success PGI-I | PQ | ✓ | ✓ | ✓ | |
Generic health status | PQ | ✓ | ✓ | ✓ | ✓ |
 EQ-5D-5L | |||||
Condition specific quality of life | PQ | ✓ | ✓ | ✓ | |
 ICIQ-LUTSqol | |||||
Urinary symptoms | PQ | ✓ | ✓ | ✓ | ✓ |
 ICIQ-OAB | |||||
 ICIQ-FLUTS | |||||
 UPS: Urgency Perception Scale | |||||
Urgency and urgency urinary incontinence episodes on (3-day bladder diary) | PQ | ✓ | ✓ | ✓ | |
Bladder scan | CRF | ✓ | |||
Interventions received | CRF, PQ | ✓ | ✓ | ✓ | |
Adverse events | CRF, PQ | ✓ | ✓ | ✓ | |
NHS primary and secondary healthcare use | CRF, PQ | ✓ | ✓ | ✓ | |
Participant resource use | PQ | ✓ | ✓ | ✓ | |