Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-11 @ 12:45 AM
Study NCT ID:
NCT01378559
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2011-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-21', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction assessed by EDITS question 1', 'timeFrame': 'Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months', 'description': 'Patient satisfaction assesed by the "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire", Question 1:\n\n1\\. Overall how satisfied are you with penile prosthesis? Very satisfied Somewhat satisfied Neither satisfied or dissatisfied Somewhat dissatisfied Very dissatisfied'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'At the beginning of study when the chart review is conducted', 'description': 'Complications may include:\n\nBleeding, Infection, Mechanical problems with the device, Erosion, Pain, Penile shortening, Auto inflation, Other complications.\n\nThe number and nature of all complications will be noted. Complications are assessed by patient chart review and a brief phone interview with the patient.'}, {'measure': 'Patient satisfaction assessed by EDITS questions 2-13', 'timeFrame': 'Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months', 'description': '"Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire" questions 2-13 include questions about:\n\nExpectations Continued use of device Ease and frequency of use Confidence Partner satisfaction Erectile function Future surgery Recommendations for others'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Penis prosthesis', 'Titan', 'Satisfaction', 'Complications'], 'conditions': ['Erectile Dysfunction', 'Intraoperative Complications', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess patient satisfaction with the Titan one touch release penis prosthesis and to register complications with this prosthesis. This will regard the first prostheses inserted at Herlev Hospital/Frederikssund Hospital.\n\nPatient satisfaction will be assessed by mailing out the "Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire" and recording the patient answers. The most important question will be "Overall how satisfied are you with penile prosthesis?".\n\nComplications (including infection, bleeding, and mechanical failure) will be assessed by a patient chart review and confirmed by a brief phone interview.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital / Frederikssund Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.\n\nExclusion Criteria:\n\n* Inability to read Danish'}, 'identificationModule': {'nctId': 'NCT01378559', 'briefTitle': 'Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis', 'orgStudyIdInfo': {'id': 'Titan-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Penis prosthesis cohort', 'interventionNames': ['Other: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire']}], 'interventions': [{'name': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire', 'type': 'OTHER', 'description': 'A questionnaire accessing satisfaction with a penis prosthesis', 'armGroupLabels': ['Penis prosthesis cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of urology, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Jens Sønksen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}