| Screening period | Operation | Observation period | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Provisional registration | Registration | Day 0 | Day 1 | At end of hospitalization | Week 2 | Week 4 | Week 12 | Week 26 | Week 38 | Week 52 | |
Eligibility criteria | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Vital signsa | Â | Â | X | X | X | X | Â | Â | Â | Â | Â |
Oxygen saturation | Â | Â | X | X | X | X | Â | Â | Â | Â | Â |
Laboratory tests | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Infectionsb |  | X |  |  |  |  |  |  |  |  |  |
 Hematologyc, Biochemistryd, CRP, Coagulatione, Urinalysisf |  | X |  | X | X | X | X | X | X |  | X |
 PSA |  | X |  |  |  |  |  | X | X |  | X |
12 Lead electrocardiography | Â | X | Â | X | X | X | Â | Â | Â | Â | Â |
Chest X-rays | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Urination diaryg | Â | X | Â | Â | Â | X | X | X | X | X | X |
QOL scoresh | Â | X | Â | Â | Â | Â | Â | Â | X | Â | X |
Patient overall satisfaction | Â | X | Â | Â | Â | Â | Â | Â | X | Â | X |
Urodynamic parametersi | Â | X | Â | Â | Â | X | X | X | X | Â | X |
Transrectal ultrasonography | Â | X | Â | Â | Â | Â | Â | X | X | Â | X |
MRI | Â | X | Â | Â | Â | X | Â | Â | X | Â | X |
Liposuction | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â |
Periurethral injection of ADRCs, and mixture of ADRCs and fat | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â |
Concomitant therapies | X | X | X | X | X | X | X | X | X | X | X |
Adverse events | X | X | X | X | X | X | X | X | X | X | X |