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

NCT07368647 | Recruiting

• 1 other identifier: STUDY02001352
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infection (Diagnosis); Radiation Cystitis

Outcome Measures

Primary Outcomes (1)

• Completion of HBOT

  Participants complete Hyperbaric Oxygen Therapy and final urine sample collection

  From enrollment to 1 year after completion of HBOT treatment

Secondary Outcomes (1)

• Completion of Specimen collection

  From enrollment until approximately 1 year after enrollment

Study Arms (4)

Cohort 1: RC with HBOT

Participants with radiation cystitis schedule for hyperbaric oxygen therapy

Other: Hyperbaric Oxygen Therapy

Cohort 2: HBOT Controls

Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation

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

Interventions

Hyperbaric Oxygen Therapy OTHER

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.

Cohort 1: RC with HBOT; Cohort 2: HBOT Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rachel A. Moses: lead
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine and blood specimens will be banked for potential future use; Radiation Cystitis participants will additionally consent to having biopsy specimens banked for future studies comparing immunohistochemical staining for bladder inflammatory marker localization validation.

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Rachel Moses, MD

CONTACT

(603) 650-5091; Rachel.A.Moses@hitchcock.org

Amanda Wittemann

CONTACT

(603)653-0654; Amanda.L.Wittemann@Hitchcock.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 26, 2026
• Study Start: April 4, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)