Recruiting

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

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Urogenital Diseases
+7

+ Disease
+ Female Urogenital Diseases and Pregnancy Complications
Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2022
See protocol details

Summary

Principal SponsorRachel A. Moses
Study ContactRachel Moses, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 4, 2022Actual date on which the first participant was enrolled.

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

Official TitleChronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers 
Principal SponsorRachel A. Moses
Study ContactRachel Moses, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

What happens to patients' samples
Samples from participants are kept, and they can be used to extract DNA in the future. These might include things like blood or frozen tissue. This allows researchers to study genetics and how DNA may relate to the disease.

Other Options for Sample Use
Samples Without DNA
: Samples are kept but not usable for DNA analysis.

None Retained
: No samples are kept after the study.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Disease
Female Urogenital Diseases and Pregnancy Complications
Infections
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Urinary Tract Infections
Urologic Diseases
Female Urogenital Diseases
Male Urogenital Diseases
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Participants complete Hyperbaric Oxygen Therapy and final urine sample collection

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Dartmouth-Hitchcock Medical CenterLebanon, United StatesSee the location

Recruiting
One Study Center
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