Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 4:45 PM
Study NCT ID:
NCT03500406
Status:
TERMINATED
Last Update Posted:
2020-01-06
First Post:
2018-04-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Penile Lengthening Pre-Penile Prosthesis Implantation
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': 'Trost.Landon@mayo.edu', 'phone': '507-284-3728', 'title': 'Dr. Landon Trost', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected three months post prosthesis implantation. However, this study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length Assessment of Penile Prosthesis Implanted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': 'From baseline to 3 months', 'description': 'The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}, {'type': 'SECONDARY', 'title': 'Participant Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': 'From baseline to 3 months', 'description': 'Compare Participant compliance with traction device', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction With Traction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': 'From baseline to 3 months', 'description': 'Compare patient reported satisfaction with use of traction device', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}, {'type': 'SECONDARY', 'title': 'Adverse Events With Use of Traction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': 'From baseline to 3 months', 'description': 'Evaluate any adverse events with use of RestoreX® for penile lengthening.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}, {'type': 'SECONDARY', 'title': 'Operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': '3, 6, 12 months post-operative', 'description': 'Compare intra- and/or post-operative complication rates.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}, {'type': 'SECONDARY', 'title': 'Stretched Penile Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': 'From baseline to 12 months', 'description': 'Compare pre- and post-operative stretched penile lengths', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction Penile Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'OG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'timeFrame': 'Baseline to 12 months post-operative', 'description': 'Compare participant satisfaction scores including satisfaction with overall penile length', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'FG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure\n\nControl: No treatment'}, {'id': 'BG001', 'title': 'Group 2 - PTT 3x Daily x 3 Months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP\n\nRestoreX: Penile traction therapy in the straight position'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.5', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-10', 'size': 394078, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-08T10:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'PI changed subspecialties and no longer had access to main study population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2018-04-09', 'resultsFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-03', 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length Assessment of Penile Prosthesis Implanted', 'timeFrame': 'From baseline to 3 months', 'description': 'The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)'}], 'secondaryOutcomes': [{'measure': 'Participant Compliance', 'timeFrame': 'From baseline to 3 months', 'description': 'Compare Participant compliance with traction device'}, {'measure': 'Participant Satisfaction With Traction', 'timeFrame': 'From baseline to 3 months', 'description': 'Compare patient reported satisfaction with use of traction device'}, {'measure': 'Adverse Events With Use of Traction', 'timeFrame': 'From baseline to 3 months', 'description': 'Evaluate any adverse events with use of RestoreX® for penile lengthening.'}, {'measure': 'Operative Complications', 'timeFrame': '3, 6, 12 months post-operative', 'description': 'Compare intra- and/or post-operative complication rates.'}, {'measure': 'Stretched Penile Length', 'timeFrame': 'From baseline to 12 months', 'description': 'Compare pre- and post-operative stretched penile lengths'}, {'measure': 'Participant Satisfaction Penile Length', 'timeFrame': 'Baseline to 12 months post-operative', 'description': 'Compare participant satisfaction scores including satisfaction with overall penile length'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.', 'detailedDescription': 'Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint post-operatively that their penis length is shorter than what it was previously.\n\nSeveral attempts have been made by investigators to optimize penile length prior to placement of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers several potential advantages in that it is minimally-invasive, does not increase the morbidity of surgery, and has not been shown to result in any long-term side effects.\n\nA new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given the clinical issue of dissatisfaction with penile length post IPP, the potential role for PTT, and limited amount of data available, we sought to perform a clinical trial evaluating the effect of PTT on increasing the total length of prosthesis which can be inserted. We additionally sought to determine if PTT resulted in improved post-operative satisfaction on total penile length achieved.\n\nTo accomplish the study, a population of men from Mayo Clinic planning to undergo placement of an IPP will be enrolled and given the option to either join the control (no treatment) group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to publish in a scientific journal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Men undergoing placement of a penile prosthesis\n* Must be the first time a penile prosthesis is implanted\n* Undergoing implantation of a 3-piece inflatable penile prosthesis\n\nExclusion Criteria\n\n* Prior ischemic priapism\n* Any prior penile prosthesis surgeries\n* Any prior penile surgeries other than circumcision\n* Undergoing malleable penile prosthesis or Ambicor device'}, 'identificationModule': {'nctId': 'NCT03500406', 'briefTitle': 'Penile Lengthening Pre-Penile Prosthesis Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Penile Lengthening Pre-Penile Prosthesis Implantation', 'orgStudyIdInfo': {'id': '17-011052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group 1 - Control', 'description': 'No treatment will be administered and men will not have to delay their IPP procedure', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - PTT 3x daily x 3 months', 'description': 'Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP', 'interventionNames': ['Device: RestoreX']}], 'interventions': [{'name': 'RestoreX', 'type': 'DEVICE', 'description': 'Penile traction therapy in the straight position', 'armGroupLabels': ['Group 2 - PTT 3x daily x 3 months']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No treatment', 'armGroupLabels': ['Group 1 - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Landon W Trost', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Landon W. Trost', 'investigatorAffiliation': 'Mayo Clinic'}}}}