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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozone Therapy Group | Experimental | Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks. |
|
| Placebo Group | Placebo Comparator | Patients received 50 mL normal saline intravesically twice weekly for 3 weeks. |
|
| Control Group | Other | Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravesical Ozone Therapy | Other | Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in O'Leary-Sant ICSI Score | Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19). | Baseline to Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain score | Reduction in pelvic pain measured by Visual Analog Scale (range 0-10). | baseline to week 3 |
| Change in Daily Urinary Frequency | Reduction in average daily voiding frequency via 3-day voiding diary. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali İhsan Memmi | Contact | 90 0537 922 0997 | alimemmi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36242631 | Background | 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. |
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Individual participant data will not be shared due to privacy concerns and the absence of a data-sharing agreement.
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo (Normal Saline) | Other | Patients received 50 mL normal saline intravesically twice weekly for 3 weeks. |
|
| Control | Other | Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention. |
|
| baseline to week 3 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |