Recruiting NCT07368647

Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers

— Observational Radiation Cystitis Urinary Tract Infection (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Hyperbaric Oxygen Therapy.
Who it may be relevant to: Registry conditions: Radiation Cystitis, Urinary Tract Infection (Diagnosis). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy

Other Hyperbaric 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.

Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration [Time frame: Baseline to 12 months post-HBOT]
Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration [Time frame: Baseline to 12 months post-HBOT]
Urinary Interleukin-6 (IL-6) concentration [Time frame: Baseline to 12 months post-HBOT]
Urinary Vascular Endothelial Growth Factor (VEGF) concentration [Time frame: Baseline to 12 months post-HBOT]

Secondary outcome measures (3)

Hematuria events [Time frame: Baseline to 12 months after enrollment]
Urogenital Distress Inventory (UDI) total score [Time frame: Baseline to 12 months after enrollment]
EQ-5D-5L Index Score [Time frame: Baseline to 12 months after enrollment]

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

United States · 1 center

NCT: NCT07368647 · STUDY02001352