V1 Baseline M-1 | Hospitalization | V2 1 month follow-up +/− 7 days | V3 3 months follow-up +/− 7 days | V4 6 months follow-up +/− 7 days | |||
---|---|---|---|---|---|---|---|
D-1 | Discharge | D0 | |||||
Patient information | ✓ | ||||||
Informed consent | ✓ | ||||||
Verification of eligibility criteria | ✓ | ||||||
Randomization | ✓ | ||||||
Clinical examination | ✓ | ✓ | ✓ | ||||
Complete biological check-up | ✓ | ✓ | |||||
CBEU | ✓ | ✓ | ✓ | ✓ | |||
PSA | ✓ | ✓ | ✓ | ||||
Ultrasound: measurement of prostatic volume and post-voiding residual | ✓ | ✓ | |||||
Uroflowmetry: measurement of Qmax | ✓ | ✓ | ✓ | ||||
IPSS and USP questionnaires | ✓ | ✓ | ✓ | ✓ | |||
Collection of patient data | ✓ | ||||||
Collection of operative data | ✓ | ||||||
Scores: CHA2DS2-VASc, HAS-BLED, ATRIA bleeding risk | ✓ | ✓ | |||||
Collection of treatments | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Collection of adverse events | ✓ | ✓ | ✓ | ✓ | ✓ |