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Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

ConditionsInterstitial CystitisBladder Pain Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years

Histopathologically or clinically confirmed IC (per AUA guidelines)

Symptoms for at least 6 months

Willing to provide informed consent

Disqualifiers

Active urinary tract infection

Bladder malignancy

Pregnancy or breastfeeding

Known ozone allergy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravesical Ozone Therapy

    Other intervention

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

  • Placebo (Normal Saline)

    Other intervention

    Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.

  • Control

    Other intervention

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Ozone Therapy GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Group C: Control GroupOther 1 intervention

Trial outcomes

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).

Time frame
Baseline to Week 3

Secondary outcomes

1

VAS pain score

Reduction in pelvic pain measured by Visual Analog Scale (range 0-10).

Time frame
baseline to week 3
2

Change in Daily Urinary Frequency

Reduction in average daily voiding frequency via 3-day voiding diary.

Time frame
baseline to week 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: