NCT06863220

Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
OTHER	Intravesical Ozone Therapy	Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
OTHER	Placebo (Normal Saline)	Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.
OTHER	Control	Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-03-07
• Last updated: 2025-04-27

Locations

1 site across 1 country: Turkey (Türkiye)