Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
Status:
Completed
Trial end date:
2018-08-09
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the relief of symptoms after Hyperbaric
Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate
cancer Index Composite (EPIC)symptom estimation scale as primary variable.
Study hypothesis:
- HBOT can reduce or reverse the change or otherwise limit the damage of the bladder
function and/or structure, which arose as a result of radiation therapy of cancer in the
pelvic region organs.
- The effects of HBOT are associated with relief of symptoms that, at least in part, is
related to the reduction of the extent of the radiation damage.
- Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as
a sign of an improved function of the mucosa.
- Treatment results of HBOT remains, in whole or in part, during the follow-up (residual
effect)