Interstitial CystitisNCT06863220
Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
A study testing Intravesical Ozone Therapy in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Intravesical Ozone Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Histopathologically or clinically confirmed IC (per AUA guidelines)
- Symptoms for at least 6 months
- Willing to provide informed consent
Who cannot join
- Active urinary tract infection
- Bladder malignancy
- Pregnancy or breastfeeding
- Known ozone allergy
- Intravesical therapy within 3 months
- G6PD deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul
Ali İhsan Memmi, +90 537 922 0997, alimemmi@gmail.com
About this study
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.
Read the 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.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- Intravesical Ozone Therapy, Placebo (Normal Saline), Control
- Keywords
- Interstitial Cystitis, bladder pain syndrome, ozone therapy, intravesical ozone
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical Ozone TherapyOther
Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.
Placebo (Normal Saline)Other
Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.
ControlOther
Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Ozone Therapy Group | Experimental | Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks. Receives: Other: Intravesical Ozone Therapy |
| Placebo Group | Placebo comparator | Patients received 50 mL normal saline intravesically twice weekly for 3 weeks. Receives: Other: Placebo (Normal Saline) |
| Control Group | Other | Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in O'Leary-Sant ICSI Score
Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).
Measured: Baseline to Week 3
Secondary outcomes (2)
VAS pain score
Reduction in pelvic pain measured by Visual Analog Scale (range 0-10).
Measured: baseline to week 3
Change in Daily Urinary Frequency
Reduction in average daily voiding frequency via 3-day voiding diary.
Measured: baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863220
- Sponsor's protocol ID
- 340434043404
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared due to privacy concerns and the absence of a data-sharing agreement.
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.
PubMed 36242631
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT06863220
- Acronym / sponsor ID
- 340434043404
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- Interstitial Cystitis, bladder pain syndrome, ozone therapy, intravesical ozone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozone Therapy Group | Experimental | Other: Intravesical Ozone TherapyPatients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks. |
| Placebo Group | Placebo comparator | Other: Placebo (Normal Saline)Patients received 50 mL normal saline intravesically twice weekly for 3 weeks. |
| Control Group | Other | Other: ControlPatients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Histopathologically or clinically confirmed IC (per AUA guidelines)
- Symptoms for at least 6 months
- Willing to provide informed consent
Key exclusion criteria (6 listed)
- Active urinary tract infection
- Bladder malignancy
- Pregnancy or breastfeeding
- Known ozone allergy
- Intravesical therapy within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical Ozone TherapyPatients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks. | Other | Ozone Therapy Group |
| Placebo (Normal Saline)Patients received 50 mL normal saline intravesically twice weekly for 3 weeks. | Other | Placebo Group |
| ControlPatients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention. | Other | Control Group |
Primary outcome
Change in O'Leary-Sant ICSI Score
Time frame: Baseline to Week 3
Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19).
2 secondary outcomes
VAS pain score
Time frame: baseline to week 3
Change in Daily Urinary Frequency
Time frame: baseline to week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 36242631Pires 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.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared due to privacy concerns and the absence of a data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravesical Ozone Therapy in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali İhsan Memmi (90 0537 922 0997, alimemmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in O'Leary-Sant ICSI Score (time frame: Baseline to Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.