Radiation Cystitis, Urinary Tract Infection (Diagnosis)
Conditions
Brief summary
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Interventions
OTHERHyperbaric Oxygen Therapy
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.
Sponsors
Rachel A. Moses
Dartmouth-Hitchcock Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Cohort 1 * At least 18 years of age * Post pelvic radiation carrying the diagnosis of moderate to severe radiation cystitis and recurrent macroscopic hematuria in the absence of infection or urothelial malignancy. The diagnosis of moderate to severe (Radiation Therapy Oncology Group (RTOG) grade 2, 3-4) RC will be made by board-certified, reconstructive Urologists routinely managing radiation cystitis patients in their practices (RM /WB,III) or co-investigator (JB) using Appendix B and confirmed with cystoscopy and negative urine cytology and/or bladder biopsy to rule out malignancy (which is standard of care of work up of hematuria as defined by the American Urology Association)45 once all other pathologies for gross hematuria have been excluded (including infection, malignancy, etc). * Scheduled to, or currently undergoing (initiated within the past 7 days), HBOT as part of standard of care therapy for radiation cystitis Cohort 2 HBOT controls * At least 18 years of age * Without a history of prior pelvic radiation * Scheduled to, or currently undergoing (initiated within the past 7 days) HBOT as part of standard of care therapy for reasons that do not include bladder inflammation) Cohort 3 Healthy controls * At least 18 years of age * Without history of pelvic radiation or HBOT Cohort 4 * At least 18 years of age * Same as Cohort 1 except they OPT-OUT of participation in HBO therapy.
Exclusion criteria
All Cohorts * Pregnant or lactating (females will be asked if there is any chance they could be pregnant). * Uncompensated heart failure, uncompensated fluid overload, or uncompensated myocardial infarction preventing therapeutic HBOT * A history of: uncontrolled seizure disorder, active urinary tract infection, active Grave's disease, cystic fibrosis, sickle cell anemia, known HIV, or any autoimmune disease not in remission that requires active systemic steroid therapy or immune modulating medications. * Refusal to sign IRB approved informed consent document * Prior participation in a clinical trial that could potentially affect immunological status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration | Baseline to 12 months post-HBOT | Change in urinary 8-OHdG measured using validated oxidative stress assays. Reported in ng/mL. |
| Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration | Baseline to 12 months post-HBOT | Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL. |
| Urinary Interleukin-6 (IL-6) concentration | Baseline to 12 months post-HBOT | Change in urinary IL-6 measured using validated cytokine immunoassays. Reported in pg/mL. |
| Urinary Vascular Endothelial Growth Factor (VEGF) concentration | Baseline to 12 months post-HBOT | Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematuria events | Baseline to 12 months after enrollment | Number of patient-reported hematuria episodes recorded at baseline, during HBOT, and follow-up. |
| Urogenital Distress Inventory (UDI) total score | Baseline to 12 months after enrollment | Change in Urogenital Distress Inventory score (range 0-100; higher scores indicate worse urinary distress). |
| EQ-5D-5L Index Score | Baseline to 12 months after enrollment | Change in EQ-5D-5L index score (range -0.281 to 1.000; higher scores indicate better health-related quality of life). |
Countries
United States
Contacts
CONTACTRachel Moses, MD
CONTACTAmanda Wittemann
Outcome results
None listed