Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-06 @ 3:02 AM
Study NCT ID:
NCT01835860
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2013-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-04-16', 'lastUpdatePostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).', 'timeFrame': '1, 3, 6 and 12 months'}]}, 'conditionsModule': {'keywords': ['BPH'], 'conditions': ['Benign Prostate Hyperplasia']}, 'descriptionModule': {'briefSummary': 'To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS\\>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living)\n2. Urinary retention (related to BPH) leading to catheterization.\n3. Refractory to medical treatment or patient is not willing to consider medical treatment\n4. Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.\n\nExclusion Criteria:\n\n1. Mild symptoms (IPSS \\<8)\n2. Moderate to severe lower urinary tract symptoms (i.e. IPSS\\>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living).\n3. Suspected malignancy.\n4. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.\n5. Advanced atherosclerosis and unsuitable vascular access.\n6. Allergy to intravenous contra'}, 'identificationModule': {'nctId': 'NCT01835860', 'briefTitle': 'Prostatic Artery Embolization for Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Saskatchewan Health Authority - Regina Area'}, 'orgStudyIdInfo': {'id': 'REB-12-81'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Embolization', 'description': 'Prostate artery embolization', 'interventionNames': ['Procedure: Prostate artery embolization']}], 'interventions': [{'name': 'Prostate artery embolization', 'type': 'PROCEDURE', 'armGroupLabels': ['Embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S4P 0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Regina General Hospital', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saskatchewan Health Authority - Regina Area', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}