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Starting soon Not applicable

Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

NCT06863220 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-04-27

Condition(s) studied

Interstitial CystitisBladder Pain Syndrome

Investigational drug(s) / intervention(s)

Intravesical Ozone TherapyPlacebo (Normal Saline)Control

Intravesical Ozone Therapy: Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.

Placebo (Normal Saline): Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.

Control: Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-65 years * Histopathologically or clinically confirmed IC (per AUA guidelines) * Symptoms for at least 6 months * Willing to provide informed consent Exclusion Criteria: * Active urinary tract infection * Bladder malignancy * Pregnancy or breastfeeding * Known ozone allergy * Intravesical therapy within 3 months * G6PD deficiency

Primary outcome measure(s)

  • Change in O'Leary-Sant ICSI Score — Baseline to Week 3
    Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).

Trial sites (1)

FacilityCityRegionStatus
İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06863220 on ClinicalTrials.gov ↗ ← All trials in Turkey