Actively Recruiting
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
Led by Rachel A. Moses · Updated on 2026-01-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rachel A. Moses
Lead Sponsor
D
Dartmouth-Hitchcock Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating chronic radiation cystitis, a condition affecting the bladder after pelvic radiation, and how hyperbaric oxygen therapy (HBOT) impacts patient-reported outcomes and urine inflammatory biomarkers. The study includes patients with radiation cystitis and other groups to compare effects and collect biological samples. The research aims to better understand the condition and the role of HBOT in treatment through observational methods. The study involves four participant groups: those with radiation cystitis undergoing HBOT, those undergoing HBOT without prior pelvic radiation, healthy controls without radiation exposure, and those with radiation cystitis who choose not to use HBOT. HBOT is delivered by placing patients in special chambers where they breathe 100% oxygen at high pressure for 80 to 90 minutes daily, for up to 60 consecutive sessions. Participants are followed through these treatment courses or observation periods depending on their group. During the study, participants provide urine, blood, and tissue samples from enrollment until about one year after completing HBOT or enrollment. Researchers will monitor completion of HBOT and sample collection, as well as track patient-reported symptoms and biomarkers related to bladder inflammation. The study collects data to assess safety and treatment impact over time, with all follow-up lasting up to one year post-treatment or enrollment.
CONDITIONS
Brief Title
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- For Cohort 1: Post pelvic radiation with moderate to severe radiation cystitis and recurrent visible blood in urine without infection or cancer, confirmed by specialists
- For Cohort 1: Scheduled for or started hyperbaric oxygen therapy within past 7 days as standard care for radiation cystitis
- For Cohort 2: At least 18 years old, no history of pelvic radiation, scheduled for or started hyperbaric oxygen therapy for reasons other than bladder inflammation
- For Cohort 3: At least 18 years old, no history of pelvic radiation or hyperbaric oxygen therapy
- For Cohort 4: At least 18 years old, same as Cohort 1 but electing not to undergo hyperbaric oxygen therapy
You will not qualify if you...
- Pregnant or breastfeeding
- Uncompensated heart failure, fluid overload, or recent heart attack preventing hyperbaric oxygen therapy
- History of uncontrolled seizures, active urinary tract infection, active Grave's disease, cystic fibrosis, sickle cell anemia, HIV, or autoimmune disease needing active steroid or immune treatment
- Refusal to sign informed consent
- Prior participation in clinical trials affecting immune status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 60 consecutive daily sessions
Participants with radiation cystitis or controls undergo hyperbaric oxygen therapy sessions as part of their routine care.
Daily visits for up to 60 sessions
Duration - Approximately 1 year after therapy or enrollment
Participants are followed for approximately 1 year after completion of therapy or enrollment to assess patient-reported outcomes and urine inflammatory biomarkers.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
R
Rachel Moses, MD
A
Amanda Wittemann
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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