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Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder (HBOTCICrUTI Trial)
Phase < 1
Waitlist Available
Led By Ian R Grover, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three year study period. determination of this endpoint will be made for each individual patient at one year after final hbot session.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if breathing pure oxygen in a pressurized chamber can help people with chronic bladder conditions that are hard to treat. The goal is to see if this method can reduce symptoms and be a feasible treatment option. Hyperbaric oxygen therapy (HBO) has been used successfully in several urologic disorders, including painful bladder syndrome/interstitial cystitis and radiation cystitis.
Eligible Conditions
- Urinary Tract Infection
- Interstitial Cystitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three year study period. determination is made for this endpoint on the date of final hbot session.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three year study period. determination is made for this endpoint on the date of final hbot session.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HBOT acceptance
HBOT adherence
Secondary study objectives
Post treatment incidence of recurrent urinary tract infection.
Interstitial Cystitis
Pre and post treatment symptom survey fro the chronic interstitial cystitis study group. The patient's overall rating of improvement of symptoms (PORIS) will be used.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hyperbaric OxygenExperimental Treatment1 Intervention
Hyperbaric oxygen therapy-2.4 atmosphere absolute for 90 minutes with 2-five minute air breaks administered daily, 5 days per week for 8 weeks total treatment.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,730 Total Patients Enrolled
Ian R Grover, MDPrincipal InvestigatorUniversity of California, San Diego