Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in O'Leary-Sant ICSI Score
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (IC). Participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. The primary outcome was the change in O'Leary-Sant ICSI score. Secondary outcomes included VAS pain score, SF-36 physical health, and urinary frequency.
详细描述
Patients received either 50 mL ozonated saline (20-40 µg/mL), normal saline (placebo), or continued standard care twice weekly for 3 weeks. Assessments were conducted at baseline, week 3, and week 6. The study aimed to determine if ozone therapy reduces interstitial cystitis symptoms compared to placebo and standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Histopathologically or clinically confirmed IC (per AUA guidelines)
- •Symptoms for at least 6 months
- •Willing to provide informed consent
排除标准
- •Active urinary tract infection
- •Bladder malignancy
- •Pregnancy or breastfeeding
- •Known ozone allergy
- •Intravesical therapy within 3 months
- •G6PD deficiency
研究组 & 干预措施
Ozone Therapy Group
Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
干预措施: Intravesical Ozone Therapy (Other)
Placebo Group
Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.
干预措施: Placebo (Normal Saline) (Other)
Control Group
Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.
干预措施: Control (Other)
结局指标
主要结局
Change in O'Leary-Sant ICSI Score
时间窗: Baseline to Week 3
Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).
次要结局
- VAS pain score(baseline to week 3)
- Change in Daily Urinary Frequency(baseline to week 3)
研究者
Ali Ihsan Memmi
urologist
Medipol University