Table 3. Schedule of Evaluations During the Off-Treatment Follow-Up Phase of the Study.
| Off-Treatment Follow-Up (Study Months 7-12) | ||||||
|---|---|---|---|---|---|---|
| 7 month Phone call | 8 month Phone call | 9 month Phone call | 10 month Phone call | 11 month Phone call | 12 month Phone call | |
| Window (days) | ±7d | ± 7d | ± 7d | ± 7d | ± 7d | ± 7d |
| PGSC1 | X | X | X | X | X | X |
| Medication & Therapy Review | X | X | X | X | X | X |
| OABq –SF2 | X | X | X | X | X | X |
| Adverse Event Screen3 | X | X | X | X | X | X |
PGSC=Patient Global Symptom Control rating
Note: Adverse events related primarily to voiding dysfunction will be collected.
Adverse Event Screen