Fig. 4
Intervention and assessment schedule for the FLEBER study according to the Recommendations for Interventional Trials (SPIRIT). Follow-up visits and data collection should occur approximately 1, 3, 6, 9, 12, 15, 18, 21, and 24 months from the surgery. Patients will complete a set of questionnaires at every visit, and follow-up information may be collected via medical charts. The Case Report Form will include information regarding past history, concomitant medications, and any medications taken after the treatment. Chest–abdomen–pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) should be performed for TNM classification. X, mandatory; *hemoglobin, hematocrit, white blood cell count and fractions, platelet count; **aspartate transaminase (AST), alanine transaminase (ALT), γ-glutamyl transpeptidase (γ-GTP), total bilirubin, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), total protein, albumin, serum creatinine, uric acid, total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, C-reactive protein (CRP), calcium, phosphorus, potassium, chloride; ***Urine dipstick test (specific gravity, pH, protein, glucose, bilirubin, urobilinogen, ketone body, and occult blood) and urine sediment test; †3 days and nights record. Patients pick days that will be convenient for them to measure and record everything; ††pain scale measures: numerical pain rating scale (NPRS), visual analog scale (VAS), and faces pain scale (FPS); †††according to the Common Toxicity Criteria for Adverse Events (CTCAE v 5.0) translated into Japanese; ††††questionnaires: SF-8™, EORTC QLQ-C30, and FACT-BL. Abbreviations: BW, body weight; BT, body temperature; BP, blood pressure; ECOG-PS, Eastern Cooperative Oncology Group-performance status scale; PDD, photodynamic diagnosis; EBTUR, en bloc transurethral resection of bladder tumor; cTURBT, conventional transurethral resection of bladder tumor; QOL, quality of life; IPSS, International Prostate Symptom Score; OABSS, overactive bladder symptom score