Evaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of the response to the use of intravesical medicinal ozone gas in patients with Interstitial Cystitis / Bladder Pain Syndrome (IC / BPS) using the O'Leary Sant Symptom and Problem Index questionnaire
研究概览
简要总结
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.
详细描述
Interstitial Cystitis / bladder pain syndrome (IC / BPS) is a debilitating pathology with a negative impact on the quality of life of patients. According to the European Society for the Study of IC / BPS (ESSIC) it is expressed as a sensation of pain, pressure or discomfort related to the urinary bladder accompanied by symptoms of the lower urinary tract. Symptoms occur in the absence of infection and obvious pelvic pathologies lasting more than six weeks.
The CI / BPS has a variety of clinical phenotypes and potential etiologies. Among the phenotypes are included cystitis (IC) associated with Hunner's ulcers, known as ESSIC BPS type 3 and without Hunner's lesion, ESSIC type 1,2. Differentiation between the sub-types is performed through cystoscopy by the presence or absence of Hunner's lesions.
The dysfunctions resulting from IC / BPS originate around the bladder, adjacent pelvic organs and part of the neural tissue that controls bladder function. Functional changes in urothelium and epithelial barrier, neurogenic inflammation and autoimmune mechanisms are involved in the development of the disease.
The urothelium is covered by a layer of glycosaminoglycans (GACs) forming a protective barrier to the underlying tissues against urinary constituents and promoting selective control of molecules towards the bladder wall.
Molecular and structural changes in the GACs layer associated with the inflammatory process cause changes in urothelial permeability allowing toxic substances and urinary cations to reach the muscle and neural layer. The loss of the urothelial barrier allows chemical, cytotoxic stimuli to come into direct contact with peripheral bladder afferent neurons with persistent sensitization, central nervous amplification and local inflammatory reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Interstitial Cystitis
- •Bladder pain Syndrome
排除标准
- •Malignant Neoplasm
- •Bladder Lithiasis.
- •Lower Tract Infections
研究组 & 干预措施
Ozone Therapy
Administration of intravesical ozone gas in patients with Interstitial cystitis/bladder pain sydrome
干预措施: Ozone (Drug)
结局指标
主要结局
Evaluation of the response to the use of intravesical medicinal ozone gas in patients with Interstitial Cystitis / Bladder Pain Syndrome (IC / BPS) using the O'Leary Sant Symptom and Problem Index questionnaire
时间窗: The O'Leary Sant Symptom and Problem Index questionnaire will be applied upon admission, after the third and sixth application of intravesical. Follow-up will be carried out monthly thereafter until the sixth month of the intervention as a response check
The O 'Leary Sant Symptom and Problem Index is validated as a self-report measure of urinary symptoms and pain and how problematic these symptoms are for individuals with IC / BPS. The measure assesses symptoms and problems of IC / BPS through four questions, generating a symptom score (ICSI), problem score (ICPI) and total severity score. Symptom scores (ICSI) range from 0 to 21 and problem scores from 0 to 16, with a combined total score of 0 to 37. ICSI and ICPI score values greater than 6 alone are considered severe symptoms. Symptom scores (ICSI) greater than 5 have 94% sensitivity and 50% specificity for the diagnosis of patients with IC / BPS. At the end of the study, the symptom score cut-off point (ICSI) below 5 will be considered as a therapeutic response measure. The problem scores will be assessed through an improvement percentage, with values greater than 75% being considered as adequacy.
次要结局
未报告次要终点
研究者
Maria Verônica de Araújo Pires
Master's Student
Anhembi Morumbi University