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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
60
Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.
Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.
İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Change in O'Leary-Sant ICSI Score
Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).
Time frame: Baseline to Week 3
VAS pain score
Reduction in pelvic pain measured by Visual Analog Scale (range 0-10).
Time frame: baseline to week 3
Change in Daily Urinary Frequency
Reduction in average daily voiding frequency via 3-day voiding diary.
Time frame: baseline to week 3
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