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Can pressurized oxygen ease bladder damage from radiation?

NCT ID NCT07368647

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study looks at how hyperbaric oxygen therapy (HBOT) affects symptoms and urine markers in people with chronic radiation cystitis, a bladder condition caused by past radiation treatment. Researchers will collect urine, blood, and tissue samples from 100 participants before, during, and after HBOT. The goal is to understand if HBOT can reduce symptoms like blood in the urine and lower the risk of urinary tract infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber)
What this could lead to
If successful, this could show that hyperbaric oxygen therapy improves symptoms and reduces urinary tract infections in people with radiation cystitis.
What could go wrong
This is an early-stage observational study with only 100 participants, so results may not apply to everyone. It is not designed to prove the therapy works, only to gather data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Potential patients will be identified in the clinical during standard of care appointments. Participants in a local hyperbarics medicine registry will be approached for their interest in participating in this study as well. Healthy volunteers will be recruited from postings on public bulletin boards and available local community ListServs. Recruitment materials are reviewed and approved by the local IRB.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

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