An interventional study of Intravesical Ozone Therapy and Placebo (Normal Saline) in Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Medipol University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Medipol University · Not applicable, Interventional, and Supportive care
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.
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
Other: Intravesical Ozone Therapy
Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.
Other: Placebo (Normal Saline)
Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.
Other: Control
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.
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
VAS pain score
Reduction in pelvic pain measured by Visual Analog Scale (range 0-10).
Time frame: baseline to week 3
Change in Daily Urinary Frequency
Reduction in average daily voiding frequency via 3-day voiding diary.
Time frame: baseline to week 3
Plan to share: Undecided — Individual participant data will not be shared due to privacy concerns and the absence of a data-sharing agreement.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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