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

Recruiting now

Conditions studied: Radiation Cystitis, Urinary Tract Infection (Diagnosis)

In brief

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

Key facts

Study ID

NCT07368647

Run by

Rachel A. Moses

People needed

100

Starts

2022-04-04

Expected to finish

2027-12-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)

Full record on ClinicalTrials.gov

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