Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Study Type
OBSERVATIONAL
Enrollment
100
Hyperbaric Oxygen Therapy (HBOT) is the only non-invasive treatment modality for Radiation Cystitis, performed by placing patients in chambers and introducing them to steep oxygen gradients (100% oxygen at a pressure of 240-250kPa) for 80 to 90 minutes per day in up to 60 consecutive sessions.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITINGUrinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
Change in urinary 8-OHdG measured using validated oxidative stress assays. Reported in ng/mL.
Time frame: Baseline to 12 months post-HBOT
Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration
Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL.
Time frame: Baseline to 12 months post-HBOT
Urinary Interleukin-6 (IL-6) concentration
Change in urinary IL-6 measured using validated cytokine immunoassays. Reported in pg/mL.
Time frame: Baseline to 12 months post-HBOT
Urinary Vascular Endothelial Growth Factor (VEGF) concentration
Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL.
Time frame: Baseline to 12 months post-HBOT
Hematuria events
Number of patient-reported hematuria episodes recorded at baseline, during HBOT, and follow-up.
Time frame: Baseline to 12 months after enrollment
Urogenital Distress Inventory (UDI) total score
Change in Urogenital Distress Inventory score (range 0-100; higher scores indicate worse urinary distress).
Time frame: Baseline to 12 months after enrollment
EQ-5D-5L Index Score
Change in EQ-5D-5L index score (range -0.281 to 1.000; higher scores indicate better health-related quality of life).
Time frame: Baseline to 12 months after enrollment
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