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.

Chronic Interstitial Cystitis

Painful Bladder Syndrome

Recurrent Urinary Tract Infection

Hyperbaric oxygen therapy provides 100% medical grade oxygen at 2.4 atmospheres of absolute pressure with a Class A multiple person chamber or Class B single person chamber. Hyperbaric chambers are classified as a Class II medical device and have been FDA cleared.

Hyperbaric Oxygen Therapy-

UCSD Hillcrest Hosptial

Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder

Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder: A Feasibility Trial

The primary outcome will be the number of patients that enroll in the study relative to the number offered enrollment and reported as a percentage of total patients offered enrollment.

The number of individuals completing the prescribed 40 treatment sessions and reported as a percentage of the number of individuals who initially enrolled in the study.

The global response assessment (GRA)will be obtained and comparison between the pre and post treatment scores will be performed. The GRA measures overall improvement with therapy. It is now used as the primary end point in clinical trials of therapies for CIC/PBS. The assessment asks: "As compared to when you started the study [treatment], how would you rate your interstitial cystitis symptoms now?" The seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved. Responders will be defined as those individuals with scores falling in the moderately and markedly improved categories. The number of responders will be reported as a percentage of total number of individuals completing 40 HBOT sessions.

The number of patients who develop recurrent urinary tract infections relative to the total number of patients receiving HBOT and reported as a percentage.

The PORIS has three questions that address the overall change in CIC/PBS, pain, and urgency after treatment as worse, no better (0% improvement), slightly improved (25%), moderately improved (50%), greatly improved (75%), or symptoms gone (100% improvement). Responders will be defined as those individuals with scores falling into the moderately or greatly improved or no symptoms categories. The number of responders will be reported as a percentage of total number of individuals completing 40 HBOT sessions.

The time in days at which a recurrent urinary tract infection is occurs will be recorded from the date following final HBOT session and reported as a mean with standard deviation.

Individual patient data will not be shared. Summarized/group data will be shared between sponsor-investigator and Co-PI's at conclusion of patient enrollment. Data will be obtained by prospective collection and analysis.

Ian Grover, MD

Professor

University of California, San Diego

Prospective pilot study to test feasibility of treating patients with chronic inflammatory conditions of the urinary bladder with hyperbaric oxygen therapy.

Treatment

Control

Total

Sex: Female, Male

Region of Enrollment

The Symbol Digit Modalities Test is a measure of cognitive processing speed. The outcome is the total number of correct digit substitutions in 90 seconds, with a possible total range of 0-120. Higher values reflect a better score/outcome than lower scores.

myopia/seizures

Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder

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