Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes a… (NCT07368647) | Clinical Trial Compass
RecruitingNot Applicable
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
United States100 participantsStarted 2022-04-04
Plain-language summary
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Completion of HBOT
Timeframe: From enrollment to 1 year after completion of HBOT treatment