Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 12:13 PM
Study NCT ID:
NCT05744908
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2023-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pentosan Polysulfate Treatment's Effectiveness
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': 'D010426', 'term': 'Pentosan Sulfuric Polyester'}], 'ancestors': [{'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "two models: with and without Hunner's ulcer"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bladder wall thickness', 'timeFrame': 'Three months', 'description': '0.3 over 3 mm 1 under 3 mm,'}, {'measure': 'improvement of lower urinary tract symptoms', 'timeFrame': 'Three months', 'description': '1 if symptoms improved, 0 if not'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': 'To examine the relationship between symptoms and quality of life before and after oral pentosan polysulfate (PPS) treatment in cases diagnosed with interstitial cystitis/painful bladder syndrome (IC/BPS).', 'detailedDescription': 'Demographic characteristics, medical history, clinical conditions, and laboratory and cystoscopic data of patients who applied to our clinic between January 2018 and December 2021 and were diagnosed with IC/BPS were retrospectively analyzed. Adult male and female patients with IC/BPS who received 300 mg/day PPS at least six months ago with complaints of pain, urge, frequency, and nocturia not associated with urinary tract infection were included in the study. In addition, pre- and post-treatment symptoms, ICSI scores, quality of life (scored between 1-4), and satisfaction were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic interstitial cystitis\n* Bladder Pain Syndrome\n\nExclusion Criteria:\n\n* Acute cystitis\n* Bladder cancer\n* Chronic prostatitis\n* Bladder stone\n* Stress incontinence'}, 'identificationModule': {'nctId': 'NCT05744908', 'briefTitle': "Pentosan Polysulfate Treatment's Effectiveness", 'organization': {'class': 'OTHER', 'fullName': 'Hisar Intercontinental Hospital'}, 'officialTitle': 'Retrospective Evaluation of the Effectiveness of Oral Pentosan Polysulfate Treatment in the Improvement of Chronic Interstitial Cystitis Symptoms', 'orgStudyIdInfo': {'id': '10.01.2023/37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "With Hunner's ulcer", 'description': 'Pentosan Polysulfate 100 mg', 'interventionNames': ['Other: Pentosan Polysulphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Without Hunner's ulcer", 'description': 'Pentosan Polysulfate 100 mg', 'interventionNames': ['Other: Pentosan Polysulphate']}], 'interventions': [{'name': 'Pentosan Polysulphate', 'type': 'OTHER', 'description': '300mg 3 times a day', 'armGroupLabels': ["With Hunner's ulcer", "Without Hunner's ulcer"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '34768', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Basri Cakiroglu', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34768', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Hisar Intercontinental Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hisar Intercontinental Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Basri Cakiroglu', 'investigatorAffiliation': 'Hisar Intercontinental Hospital'}}}}