Radiation CystitisNCT07368647
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
An observational study of Radiation Cystitis and Urinary Tract Infection (Diagnosis), run by Rachel A. Moses at 1 site in United States.
Trial summary
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Cystitis, Urinary Tract Infection (Diagnosis)
- What is being tested?
- Hyperbaric Oxygen Therapy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Amanda Wittemann, (603) 653-0654, Crystallee.J.Salls@Hitchcock.org
Crystallee Salls, (603) 653-0495, Crystallee.J.Salls@Hitchcock.org
About this study
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
Hyperbaric Oxygen Therapy (HBOT) is the only non-invasive treatment modality for Radiation Cystitis, performed by placing patients in chambers and introducing them to steep oxygen gradients (100% oxygen at a pressure of 240-250kPa) for 80 to 90 minutes per day in up to 60 consecutive sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: RC with HBOT | Participants with radiation cystitis schedule for hyperbaric oxygen therapy Receives: Other: Hyperbaric Oxygen Therapy | |
| Cohort 2: HBOT Controls | Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation Receives: Other: Hyperbaric Oxygen Therapy | |
| Cohort 3: Healthy Controls | Age and gender matched controls with no history of radiation exposure | |
| Cohort 4: RC with no HBOT | Participants with radiation cystitis who elect not to undergo hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
Change in urinary 8-OHdG measured using validated oxidative stress assays. Reported in ng/mL.
Measured: Baseline to 12 months post-HBOT
Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration
Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL.
Measured: Baseline to 12 months post-HBOT
Urinary Interleukin-6 (IL-6) concentration
Change in urinary IL-6 measured using validated cytokine immunoassays. Reported in pg/mL.
Measured: Baseline to 12 months post-HBOT
Urinary Vascular Endothelial Growth Factor (VEGF) concentration
Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL.
Measured: Baseline to 12 months post-HBOT
Secondary outcomes (3)
Hematuria events
Number of patient-reported hematuria episodes recorded at baseline, during HBOT, and follow-up.
Measured: Baseline to 12 months after enrollment
Urogenital Distress Inventory (UDI) total score
Change in Urogenital Distress Inventory score (range 0-100; higher scores indicate worse urinary distress).
Measured: Baseline to 12 months after enrollment
EQ-5D-5L Index Score
Change in EQ-5D-5L index score (range -0.281 to 1.000; higher scores indicate better health-related quality of life).
Measured: Baseline to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start4 Apr 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rachel A. Moses
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Sponsor-investigator, Rachel A. Moses, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368647
- Sponsor's protocol ID
- STUDY02001352
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT07368647
- Acronym / sponsor ID
- STUDY02001352
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rachel A. MosesUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: RC with HBOT | – | Other: Hyperbaric Oxygen TherapyParticipants with radiation cystitis schedule for hyperbaric oxygen therapy |
| Cohort 2: HBOT Controls | – | Other: Hyperbaric Oxygen TherapyParticipants schedule for hyperbaric oxygen therapy without a history of pelvic radiation |
| Cohort 3: Healthy Controls | – | –Age and gender matched controls with no history of radiation exposure |
| Cohort 4: RC with no HBOT | – | –Participants with radiation cystitis who elect not to undergo hyperbaric oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy (HBOT) is the only non-invasive treatment modality for Radiation Cystitis, performed by placing patients in chambers and introducing them to steep oxygen gradients (100% oxygen at a pressure of 240-250kPa) for 80 to 90 minutes per day in up to 60 consecutive sessions. | Other | Cohort 1: RC with HBOT, Cohort 2: HBOT Controls |
Primary outcome
Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
Time frame: Baseline 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) concentration
Time frame: Baseline to 12 months post-HBOT
Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL.
Urinary Interleukin-6 (IL-6) concentration
Time frame: Baseline 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) concentration
Time frame: Baseline to 12 months post-HBOT
Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL.
3 secondary outcomes
Hematuria events
Time frame: Baseline to 12 months after enrollment
Urogenital Distress Inventory (UDI) total score
Time frame: Baseline to 12 months after enrollment
EQ-5D-5L Index Score
Time frame: Baseline to 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Cystitis and Urinary Tract Infection (Diagnosis), run by Rachel A. Moses at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Moses, MD ((603) 650-5091, Rachel.A.Moses@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration (time frame: Baseline to 12 months post-HBOT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.