Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedApril 27, 2025
March 1, 2025
10 months
March 3, 2025
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in O'Leary-Sant ICSI Score
Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).
Baseline to Week 3
Secondary Outcomes (2)
VAS pain score
baseline to week 3
Change in Daily Urinary Frequency
baseline to week 3
Study Arms (3)
Ozone Therapy Group
EXPERIMENTALPatients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
Placebo Group
PLACEBO COMPARATORPatients received 50 mL normal saline intravesically twice weekly for 3 weeks.
Control Group
OTHERPatients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18-65 years
- Histopathologically or clinically confirmed IC (per AUA guidelines)
- Symptoms for at least 6 months
- Willing to provide informed consent
You may not qualify if:
- Active urinary tract infection
- Bladder malignancy
- Pregnancy or breastfeeding
- Known ozone allergy
- Intravesical therapy within 3 months
- G6PD deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Related Publications (1)
Pires MV, de Lima CJ, Carvalho HC, Moreira LH, Fernandes AB. Effectiveness of intravesical ozone in interstitial cystitis by the O'Leary-Sant symptom index. Int Urogynecol J. 2023 Jul;34(7):1437-1446. doi: 10.1007/s00192-022-05383-3. Epub 2022 Oct 15.
PMID: 36242631BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- urologist
Study Record Dates
First Submitted
March 3, 2025
First Posted
March 7, 2025
Study Start
June 1, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 27, 2025
Record last verified: 2025-03