Overview

Evaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis /Bladder Pain Syndrome

Status:
Active, not recruiting

Trial end date:
2021-03-01

Target enrollment:
0

Participant gender:
Female

Summary

Interstitial Cystitis / bladder pain syndrome (CI / BPS) is a debilitating pathology with a negative impact on the quality of life of affected individuals. It is characterized as the sensation of pain or discomfort related to the urinary bladder, accompanied by symptoms of the lower urinary tract, in the absence of infection. Among the phenotypes are Cystitis with Hunner's ulcer, essentially inflammatory pathology and without Hunner's lesion, non-inflammatory frequently associated with somatoform systemic changes. Functional changes in urothelium and epithelial barrier, neurogenic inflammation and autoimmune mechanisms are involved in the development of the disease. Medical ozone has anti-inflammatory, antioxidant, cytoprotective, antimicrobial and immunomodulatory properties. When administered, it is dissolved in biological fluids, immediately reacting with glycoproteins composed of carbohydrates and polypeptide chains. This reaction results in the formation of hydrogen peroxide (H2O2), lipid oxidation products (LOS), increased activation of erythroid-related nuclear transcription factors (Nrf2) activation of antioxidant response transcription elements (ARE) and increased variety of antioxidant enzymes that act as free radical scavengers. Benefits of O3 have been demonstrated in the treatment of neuropathic pain and hyperalgesia associated with the analgesic and anti-inflammatory effect. The objective of this work is to evaluate the effect of intravesical ozone gas administration in patients with Interstitial Cystitis / Painful Bladder Syndrome with low response to conventional therapy.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Anhembi Morumbi University

Criteria

Inclusion Criteria:

- Interstitial Cystitis

- Bladder pain Syndrome

Exclusion Criteria:

- Malignant Neoplasm

- Bladder Lithiasis.

- Lower Tract Infections