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

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

Study Overview

• Status: Recruiting
• Conditions: Radiation Cystitis; Urinary Tract Infection (Diagnosis)
• Intervention / Treatment: Other: Hyperbaric Oxygen Therapy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Rachel Moses, MD; Phone Number: (603) 650-5091; Email: Rachel.A.Moses@hitchcock.org
• Study Contact Backup: Name: Amanda Wittemann; Phone Number: (603)653-0654; Email: Amanda.L.Wittemann@Hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Amanda Wittemann; Phone Number: (603) 653-0654; Email: Crystallee.J.Salls@Hitchcock.org
      • Contact: Crystallee Salls; Phone Number: (603) 653-0495; Email: Crystallee.J.Salls@Hitchcock.org
      • Principal Investigator: Rachel Moses, MD
      • Sub-Investigator: Jay Buckey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: RC with HBOT; Participants with radiation cystitis schedule for hyperbaric oxygen therapy	Other: Hyperbaric Oxygen Therapy; 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 2: HBOT Controls; Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation	Other: Hyperbaric Oxygen Therapy; 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 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of HBOT	Participants complete Hyperbaric Oxygen Therapy and final urine sample collection	From enrollment to 1 year after completion of HBOT treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Specimen collection	For healthy controls and radiation cystitis patients not undergoing HBOT,	From enrollment until approximately 1 year after enrollment

Collaborators and Investigators

• Sponsor: Rachel A. Moses
• Collaborators: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Pathological Conditions, Signs and Symptoms; Disease; Urinary Tract Infections; Therapeutics; Respiratory Therapy; Oxygen Inhalation Therapy; Hyperbaric Oxygenation
• Other Study ID Numbers: STUDY02001352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No