Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 10:22 PM
Study NCT ID:
NCT00731666
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'usdibe@coloplast.com', 'phone': '612-302-4990', 'title': 'Clinical Trials Manager', 'organization': 'Coloplast Corp'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 24 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Infection', 'notes': 'Procedure-related infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Study's Primary Objective Will Assess the Change in Penile Length.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP'}], 'classes': [{'title': 'Pubic bone to meatus - erect', 'categories': [{'measurements': [{'value': '1.14', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': 'Pubic bone to meatus - flaccid', 'categories': [{'measurements': [{'value': '0.99', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Pubic bone to meatus - stretched', 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': 'Pubic bone to proximal end of corona - erect', 'categories': [{'measurements': [{'value': '0.94', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Pubic bone to proximal end of corona - flaccid', 'categories': [{'measurements': [{'value': '0.69', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Pubic bone to proximal end of corona - stretched', 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'Pubopenile skin junction to meatus - erect', 'categories': [{'measurements': [{'value': '0.93', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Pubopenile skin junction to meatus - flaccid', 'categories': [{'measurements': [{'value': '0.71', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Pubopenile skin junction to meatus - stretched', 'categories': [{'measurements': [{'value': '0.95', 'spread': '1.98', 'groupId': 'OG000'}]}]}, {'title': 'Pubopenile skin junct to prox end of corona-erect', 'categories': [{'measurements': [{'value': '0.93', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Pubopenile skin junct to prox end of corona-flacci', 'categories': [{'measurements': [{'value': '0.75', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Pubopenile skin junct to prox end of corona-stretc', 'categories': [{'measurements': [{'value': '0.64', 'spread': '2.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP'}], 'classes': [{'title': 'At 12 mo: Over past 4 wks, completely satisfied', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}]}]}, {'title': 'At 12 mo: Over past 4 wks, mostly satisfied', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'At 12 mo: Over past 4 weeks, somewhat dissatisfied', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}, {'title': 'At 12 mo: Over past 4 wks, completely dissatisfied', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': 'At 24 mo: Over past 4 wks, completely satisfied', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'At 24 mo: Over past 4 wks, mostly satisfied', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'At 24 mo: Neutral', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'At 24 mo: Over past 4 weeks, somewhat dissatisfied', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'At 24 mo: Over past 4 weeks, completely dissatisfi', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects implanted with Titan IPP'}, {'type': 'SECONDARY', 'title': 'The Rate of Change in Male Stress Urinary Incontinence(SUI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP'}], 'classes': [{'title': 'Question 1: Improved', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Question 1: Unchanged (Satisfactory)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Question 1: Worsened', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Question 2: Improved', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': 'Question 2: Unchanged (Satisfactory)', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}]}]}, {'title': 'Question 2: Worsened', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}]}]}, {'title': 'Question 3: Improved', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'Question 3: Unchanged (Satisfactory)', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}]}]}, {'title': 'Question 3: Unchanged (Unsatisfactory)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Question 3: Worsened', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Subject responses to 3 questions were evaluated:\n\n1. On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?\n2. Overall, how often have you needed to change your daily activities because of urinary incontinence?\n3. Overall, how big of a social problem has urinary incontinence been for you during the past month?', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2008-08-07', 'resultsFirstSubmitDate': '2013-09-27', 'studyFirstSubmitQcDate': '2008-08-08', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-27', 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Study's Primary Objective Will Assess the Change in Penile Length.", 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.', 'timeFrame': '12 and 24 months'}, {'measure': 'The Rate of Change in Male Stress Urinary Incontinence(SUI).', 'timeFrame': '12 months', 'description': 'Subject responses to 3 questions were evaluated:\n\n1. On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?\n2. Overall, how often have you needed to change your daily activities because of urinary incontinence?\n3. Overall, how big of a social problem has urinary incontinence been for you during the past month?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['penile length', 'IPP', 'Erectile dysfunction'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '25872574', 'type': 'DERIVED', 'citation': 'Henry GD, Carrion R, Jennermann C, Wang R. Prospective evaluation of postoperative penile rehabilitation: penile length/girth maintenance 1 year following Coloplast Titan inflatable penile prosthesis. J Sex Med. 2015 May;12(5):1298-304. doi: 10.1111/jsm.12833. Epub 2015 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has an estimated life expectancy of more than 5 years\n* Has been diagnosed with erectile dysfunction\n* Is willing to have the Titan IPP implanted\n* Is able and willing to complete all follow-up visits and procedures indicated in this protocol\n* Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site\n\nExclusion Criteria:\n\n* Participant has had a previous penile prosthesis or prior penile enlargement surgeries\n* Participant has a compromised immune system\n* Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment\n* Participant does not have manual dexterity or mental ability to operate the pump\n* Participant has an active urogenital infection or active skin infection in region of surgery\n* Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease\n* Participant is diagnosed with Chordee\n* Participant has neuropathy\n* Participant has a serious bleeding disorder or coagulopathy"}, 'identificationModule': {'nctId': 'NCT00731666', 'briefTitle': 'Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation', 'orgStudyIdInfo': {'id': 'US001SU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Titan® IPP', 'description': 'Subjects implanted with Titan® IPP', 'interventionNames': ['Device: Inflatable Penile Prosthesis']}], 'interventions': [{'name': 'Inflatable Penile Prosthesis', 'type': 'DEVICE', 'otherNames': ['Titan'], 'description': 'Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.', 'armGroupLabels': ['Titan® IPP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'James A Haley VA', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Gerard Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regional Urology, LLC'}, {'name': 'Rafael Carrion, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JAames A Haley VA'}, {'name': 'Run Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}