Patient Reported Outcome Measures following Hyperbaric Oxygen Therapy for Radiation Cystitis: A Multicenter Registry for Hyperbaric Oxygen Therapy Consortium
Rachel Moses, MD1, Eileen Brandes, MD1, Kevin Krughoff, MD1, Devin Cowan, BS2, Nicole Harlan, MD1, Judy Rees, PhD,MPH3, William Bihrle, III, MD1, Jay Buckey, Jr., MD3.
1Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA, 2Dartmouth College, Hanover, NH, USA, 3Dartmouth Geisel School of Medicine, Hanover, NH, USA.
BACKGROUND: Prior studies evaluating hyperbaric oxygen therapy (HBOT) have demonstrated reduced bladder bleeding interventions, however, few U.S. studies have evaluated HBOT’s association with patient reported outcome measures (PROMs). The purpose of this study is to evaluate the feasibility of collecting PROMs of patient reported hematuria events and bladder symptoms before and after HBOT through a multi-institutional registry.
METHODS: Prospectively collected data from 16 sites in the Multicenter Registry for Hyperbaric Oxygen Therapy Consortium were analyzed. Measures included a hematuria scale adapted from the RTOG/EROCT radiation scale for cystitis, Urinary Distress Inventory (UDI) and a question on hematuria severity and quantity. Data obtained on the first and last days of HBOT were compared using Wilcoxon rank sum test. Proportions were compared using chi-square tests.
RESULTS: 52 patients had complete RTOG/EROTC hematuria data, 26 had UDI data and 32 had both. Patients were on average 73 (+/- 17) years old, 16/52 were diabetic, 27/52 are current or former smokers and 39/52 developed radiation cystitis due to prostate cancer related radiation treatment. Referral for HBOT occurred approximately 6.5 +/-5.3yrs following radiation. All patients had >30 treatments. RTOG/EROTC hematuria scores were significantly improved post HBOT (2.3 pre vs 1.1 post, p=0.0001), as was self-reported hematuria (p=0.02) (Figure 1A); UDI scores improved, but the difference was not statistically significant (33.9+/-28.3 vs 27.9+/-23.0, p=0.53) (Figure 1B). Those with UDI scores above the median pre-HBOT, did show significant reduction post (p=0.004).
CONCLUSIONS: In a novel, multi-institutional prospective data set, we demonstrate the feasibility of collecting PROMs in patients undergoing HBOT. HBOT reduced patient reported hematuria events significantly, but did not consistently reduce UDI scores in the small sample of patients with complete UDI data. Continued expansion of the registry may provide more generalizable results and allow for analysis of factors leading to improved or worsening UDI scores.
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