Pre-baseline | Baseline | Treatment | Post-treatment | Post-randomisation | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
3–6 months | 6 months | 1 year | 3 years | 6 months | 1 year | 2 years | 3 years | ||||
Pre-screening and eligibility | X | ||||||||||
Informed consent | X | ||||||||||
Randomisation | X | ||||||||||
Interventions | X | ||||||||||
Data collected by site staff | |||||||||||
- Case report forms | X | X | X | X | X | X | X | ||||
- Adverse events | X | X | X | X | X | X | |||||
Participant Questionnaires | |||||||||||
- ICIQ-UI-SF | X | X | X | X | X | ||||||
- PISQ-IR | X | X | X | X | |||||||
- EQ-5D-5L | X | X | X | X | X | ||||||
- PGI-I | X | X | X | ||||||||
- Non secondary care resource use | X | X | |||||||||
Secondary care resource use | X | X | |||||||||
Interview Study | |||||||||||
- Qualitative interview (patients) | X | X | X | X | |||||||
- Qualitative interview (staff) | X |