Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06863220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in O'Leary-Sant ICSI Score", 'timeFrame': 'Baseline to Week 3', 'description': "Reduction in symptom severity measured by the O'Leary-Sant Interstitial Cystitis Symptom Index (range 0-19)."}], 'secondaryOutcomes': [{'measure': 'VAS pain score', 'timeFrame': 'baseline to week 3', 'description': 'Reduction in pelvic pain measured by Visual Analog Scale (range 0-10).'}, {'measure': 'Change in Daily Urinary Frequency', 'timeFrame': 'baseline to week 3', 'description': 'Reduction in average daily voiding frequency via 3-day voiding diary.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial Cystitis', 'bladder pain syndrome', 'ozone therapy', 'intravesical ozone'], 'conditions': ['Interstitial Cystitis', 'Bladder Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '36242631', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Histopathologically or clinically confirmed IC (per AUA guidelines)\n* Symptoms for at least 6 months\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Active urinary tract infection\n* Bladder malignancy\n* Pregnancy or breastfeeding\n* Known ozone allergy\n* Intravesical therapy within 3 months\n* G6PD deficiency'}, 'identificationModule': {'nctId': 'NCT06863220', 'briefTitle': 'Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome', 'orgStudyIdInfo': {'id': '340434043404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozone Therapy Group', 'description': 'Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.', 'interventionNames': ['Other: Intravesical Ozone Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.', 'interventionNames': ['Other: Placebo (Normal Saline)']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Intravesical Ozone Therapy', 'type': 'OTHER', 'description': 'Patients received 50 mL ozonated saline (20-40 µg/mL) intravesically twice weekly for 3 weeks.', 'armGroupLabels': ['Ozone Therapy Group']}, {'name': 'Placebo (Normal Saline)', 'type': 'OTHER', 'description': 'Patients received 50 mL normal saline intravesically twice weekly for 3 weeks.', 'armGroupLabels': ['Placebo Group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Patients continued standard care (e.g., oral pentosan polysulfate) without intravesical intervention.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ali İhsan Memmi', 'role': 'CONTACT', 'email': 'alimemmi@gmail.com', 'phone': '+90 537 922 0997'}], 'facility': 'İstanbul Başakşehir Çam Ve Sakura Şehir Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ali İhsan Memmi', 'role': 'CONTACT', 'email': 'alimemmi@gmail.com', 'phone': '90 0537 922 0997'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will not be shared due to privacy concerns and the absence of a data-sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'urologist', 'investigatorFullName': 'Ali Ihsan Memmi', 'investigatorAffiliation': 'Medipol University'}}}}