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Hyperbaric Oxygen Therapy for Chronic Radiation Cystitis

This study is looking at how Hyperbaric Oxygen Therapy (HBOT) affects people with chronic radiation cystitis (bladder inflammation caused by radiation treatment) and recurrent macroscopic hematuria (blood in the urine that you can see). HBOT involves breathing 100% oxygen in a special chamber for about 80-90 minutes daily, for up to 60 sessions. Researchers will measure certain markers in your urine, like 8-OHdG, TNF-α, and IL-6, to see if HBOT helps reduce inflammation. You may be able to join if you are at least 18 years old and have moderate to severe radiation cystitis. The study is currently observational, meaning researchers are watching what happens to people already receiving HBOT, and the enrollment status is unclear. The goal is to understand if HBOT improves patient-reported outcomes and reduces inflammation.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not specified if it's randomized or blinded.
What's involved
The study involves the collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after HBOT to measure urinary markers.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07368647

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

Recruiting
Not specifiedAges 18+Observational
Rachel A. Moses
~100 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Hyperbaric Oxygen Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
Measured over Baseline to 12 months post-HBOT
+3 more outcomes measured

Conditions

Radiation Cystitis
Urinary Tract Infection (Diagnosis)

Explore related trials

Radiation Cystitis

NCT07368647

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshirestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Rachel Moses, MD
[email protected]
(603) 650-5091
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentrationBaseline 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) concentrationBaseline to 12 months post-HBOT

    Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL.

  • Urinary Interleukin-6 (IL-6) concentrationBaseline 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) concentrationBaseline to 12 months post-HBOT

    Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL.