Bladder Pain Syndrome, Interstitial Cystitis
Conditions
Keywords
Interstitial Cystitis, bladder pain syndrome, ozone therapy, intravesical ozone
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.
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
OTHERIntravesical Ozone Therapy
Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
OTHERPlacebo (Normal Saline)
Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.
OTHERControl
Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain score | baseline to week 3 | Reduction in pelvic pain measured by Visual Analog Scale (range 0-10). |
| Change in Daily Urinary Frequency | baseline to week 3 | Reduction in average daily voiding frequency via 3-day voiding diary. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAli İhsan Memmi
Outcome results
None listed