Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 3:56 AM
Study NCT ID:
NCT01056666
Status:
COMPLETED
Last Update Posted:
2011-09-19
First Post:
2010-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on quality of life', 'timeFrame': 'Days 0, 15, 30'}], 'secondaryOutcomes': [{'measure': 'Efficacy (leakages)', 'timeFrame': 'days 13, 14, 15 and days 28, 29, 30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18\n* Out clinic patient\n* Patient using absorbent protection for his urinary incontinence\n* Moderate to severe urinary incontinence (1 hour pad test \\> 10g)\n* All kind of stable urinary incontinence\n* Patient able to apply himself the device\n* Patient able to understand the questions\n* Patient having given his informed consent\n* Patient whose overall treatment for his urinary incontinence is not modified during the study\n\nExclusion Criteria:\n\n* Patient having a retracted penis\n* Patient having skin problem on the penis\n* Patient using urisheaths\n* Bedridden patient\n* Institutionalized patient\n* Patient with indwelling catheter or under intermittent catheterisation\n* Patient with fecal incontinence leading to the use of absorbent protection\n* Patient suffering of urinary tract infection'}, 'identificationModule': {'nctId': 'NCT01056666', 'briefTitle': 'Conveen Optima Urisheaths With Collecting Bags Versus Absorbents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': "Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle", 'orgStudyIdInfo': {'id': 'FR002CC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conveen optima urisheaths', 'interventionNames': ['Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'absorbent protections', 'description': 'The patient use their usual absorbent protection as comparator. All brands are allowed.', 'interventionNames': ['Device: absorbent protection']}], 'interventions': [{'name': 'Conveen Optima is a urisheath to be used together with a collecting bag for urine', 'type': 'DEVICE', 'description': 'Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis', 'armGroupLabels': ['Conveen optima urisheaths']}, {'name': 'absorbent protection', 'type': 'DEVICE', 'description': 'The patient use his usual absorbent protection (same brand), and change it when needed', 'armGroupLabels': ['absorbent protections']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pierre Costa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Caremeau Nimes. France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}