Table 2.
Timeline of visits/calls and measures through primary 6 Month Outcome
| Baseline/ screening |
Inject /FSLP^ |
3d call‡ | 2wk visit‡ | Implantation‡ | 1m visit† | 2m call† |
3m visit† |
4m call† | 5m call† | 6m visit † | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Window | 1–4 wk period |
3±2d | 7–14d (Interstim) /10–14d (Botox) |
8–18d (Interstim) |
30±10d | 61±10d | 91±10d | 122±10d | 152±10d | 183±10d | |
| Consent | X | ||||||||||
| Biomarker/DNA collection | X | ||||||||||
| Hx/PE | X | ||||||||||
| Timed Up and Go | X | ||||||||||
| Urodynamic assessment | X | ||||||||||
| Serum creatinine | X | ||||||||||
| Preg test~ | X | ||||||||||
| Urine dip~ | X | X* | X* | X* | X* | X* | |||||
| PVR | X | X* | X* | X* | X* | ||||||
| Adv Events/voiding assessment | X | X/X* | X/X* | X** | X/X* | X/X* | X/X* | X/X* | X/X* | X/X* | |
| Bladder diary # | X | X | X | X | X | X | X | X | |||
| PGSC and OABq-SF | X (only OABq) | X | X | X | X | X | X | ||||
| Icon Programmer/ Device data** | X** | X** | X** | ||||||||
| Iconic Questionnaire ** | X** | X** | |||||||||
| IIQ-SF, UDI-SF, PISQ-12/R, Vaizey, Sandvik, Life-Space Assessment, HUI-3 | X | X | |||||||||
| PGII and OAB-SATq | X | ||||||||||
| ConMeds | X | X | X | X | X | X | X | X | X | X | X |
^
<2 months (61 days after completion baseline/screening phase)
‡
Relative to first injection or FSLP for those treated, to final decision to not treat for those not treated
†
Relative to first injection or final implantation/removal of device, to final decision to not treat for those not treated
*
Botox subjects only
**
InterStim subjects only
~
Also at before any subsequent reinjection or revision of surgery
#
Typically obtained during week prior to visit/call