Table 1.
Phenotyping Domains, Case Report Forms (CRFs) and Timetable for Data Capture and Biological Samples Collection
| Screening/Run-in Period: Weeks 0, 1, 2, 3 | In-Clinic Deep Phenotyping Visits: Week 4; Months 6, 18, 36/ATLAS Visits | On-Line Quarterly Contacts: Months 3, 9, 15, 21, 27, 33 | On-Line with In-Clinic Option Contacts: Months 12, 24, 30 | |
|---|---|---|---|---|
| DEMO | Consent & Eligibility Confirmation† | |||
| UROLOGIC, NEUROSCAN, QST | Urine Dipstick/Culture | Urine Dipstick/Culture | Urine Dipstick/Culture | |
| SYM-Qs/Flare Status | SYM-Qs/Flare Status | SYM-Qs/Flare Status | SYM-Qs/Flare Status | |
| GRA (Run-In only) | GRA | GRA | GRA | |
| RICE; GUPIs; IC-SI/PI | RICE; GUPIs; IC-SI/PI, AUASI | RICE; GUPIs; IC-SI/PI | RICE; GUPIs; IC-SI/PI | |
| Pelvic Exam/ CystoHx† | Pelvic Exam | |||
| History: Med., Inf, Fam, Antibiotics† | Hx Antibiotics | Hx Antibiotics | ||
| Medications/PTHX† | Medications/PTHX | Medications (monthly) | Medications/PTHX | |
| Bladder Impact; SEAR, FSFI, IIEF, EFS | ||||
| Neuroimaging Scans; QST Measures | ||||
| BIO-SPECIMENS | Microbiome Urine (VB1, VB2, VB3) ¥ | Blood Collection: plasma, STIM tubes# | Blood Collection: plasma | |
| Vaginal and Rectal Swabsƛ | Biomarker Urine: spot urine | Biomarker Urine: spot urine | ||
| Microbiome Urine (VB1, VB2, VB3)¥ | Microbiome Urine (VB2)ŧ | |||
| Saliva (cortisol)€
Vaginal and Rectal Swabsƛ |
||||
| NON-UROLOGIC/PSYCHOCOCIAL | BPI/CHOIR Body Map | BPI/CHOIR Body Map | BPI/CHOIR Body Map | BPI/CHOIR Body Map |
| PainDetect | PainDetect | PainDetect | PainDetect | |
| McGill Pain; Gracely Box Scales | ||||
| CMSI checklist & Fibromyalgia module | CMSI checklist (Incl. CMSI modules) | CMSI checklist & Fibromyalgia module | CMSI checklist & Fibromyalgia module | |
| WHO-DAS | WHO-DAS, SF12 | WHO-DAS | WHO-DAS, SF12 | |
| IPAQ, WPAI, PANAS | IPAQ, WPAI, PANAS | |||
| HADS | HADS | HADS | HADS | |
| PROMIS: Fatigue, Sleep | PROMIS: Fatigue, Sleep | PROMIS: Fatigue, Sleep | PROMIS: Fatigue, Sleep | |
| MASQ | MASQ | |||
| Perceived Stress | Perceived Stress | Perceived Stress | Perceived Stress | |
| Catastrophizing; Personality: TIPI§ | ||||
| Trauma: CTES†; RTES†Ŧ |
*
Demographic/Urological: Optional In-Clinic visit@12,24,30 months.
†
W0
Ŧ
Follow-up
§
W4
#
STIM tubes: LPS (TLR4 agonist), FSL (TLR-2 agonist), and NULL (control) stimulated plasma collected at W4, M6, M18
¥
Microbiome urine full set (VB1, VB2, VB3) collected only at W0, M18 & any In-Clinic visit if participant is experiencing a flare; Only VB2 collection at M6, M36
ŧ
Microbiome (VB1, VB2, VB3) is collected at optional visits M12, 24, 30 if participant is experiencing a flare
€
Salivette 3-day (am+pm) collected at W4; Salivette 7-day (am+pm) collected at M6, M18, M36
ƛ
Vaginal and Rectal swabs only collected at W0, M18.