Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravesical Ozone Therapy, Placebo (Normal Saline), Control.
- Who it may be relevant to
- Registry conditions: Interstitial Cystitis, Bladder Pain Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in O'Leary-Sant ICSI Score [Time frame: Baseline to Week 3]
Secondary outcome measures (2)
- VAS pain score [Time frame: baseline to week 3]
- Change in Daily Urinary Frequency [Time frame: baseline to week 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi — Istanbul
Publications
- 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 36242631
Identifiers
NCT: NCT06863220 · 340434043404