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

Rachel A. Moses

Status

Enrolling

Conditions

Urinary Tract Infection (Diagnosis)

Radiation Cystitis

Treatments

Other: Hyperbaric Oxygen Therapy

Study type

Observational

Funder types

Other

Identifiers

STUDY02001352

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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