Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-22 @ 3:57 AM
Study NCT ID:
NCT05646602
Status:
WITHDRAWN
Last Update Posted:
2023-10-10
First Post:
2022-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010411', 'term': 'Penile Induration'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003012', 'term': 'Microbial Collagenase'}], 'ancestors': [{'id': 'D017364', 'term': 'Collagenases'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Following enrollment men will be randomized based on the severity of their penile curvature. Separate randomization tables will be established for men with penile curvature (i) 30 to \\< 60 degrees and (ii) 60-90 degrees. Patients will be randomized in a 1:1 ratio to CCH + LiSWT versus CCH alone within each severity cohort, with the intention to enroll a similar number of patients within each severity group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in penile curvature', 'timeFrame': 'Baseline, 10 weeks', 'description': 'Measured with a goniometer after artificial erection reported in degree unit of measurements'}], 'secondaryOutcomes': [{'measure': 'Change in Sexual function', 'timeFrame': 'Baseline, 10 weeks', 'description': 'Measured using the Sexual Encounter Profile (SEP) questions 2 and 3 to assess functional outcomes on a scale of 0=no sexual activity/did not attempt intercourse; 1=almost never/never; 2=A few times (much less than half the time); 3=Sometimes (about half the time); 4=Most times (much more than half the time); 5=Almost always/always'}, {'measure': 'Change in penile length', 'timeFrame': 'Baseline, 10 weeks'}, {'measure': 'Li-SWL related pain at therapy sessions', 'timeFrame': '6 weeks', 'description': 'Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peyronie Disease', 'Penile Curvature', 'Erectile Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Peyronie's Disease (PD) at any stage\n* The presence of penile plaque or pain at erection or curvature\n* PD therapy with or without simultaneous intralesional Xiaflex injection.\n\nExclusion Criteria:\n\n* Prior penile surgery or LiSWT.\n* Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections.\n* Unwillingness or inability to provide informed consent.\n* Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications"}, 'identificationModule': {'nctId': 'NCT05646602', 'briefTitle': "Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Impact of Focused Low-intensity Shockwave Therapy (LiSWT) in Penile Disorders (Peyronie's Disease, Erectile Dysfunction, or Both), With or Without Intralesional Clostridial Collagenase (Xiaflex) Injection, Compared With Radial Shock Wave Therapy or Xiaflex Therapy", 'orgStudyIdInfo': {'id': '22-001663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagenase Clostridium Histolyticum with LiSWT for PD Group', 'description': "Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).", 'interventionNames': ['Drug: Collagenase Clostridium Histolyticum', 'Device: Duolith SD1 T-TOP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Collagenase Clostridium Histolyticum for PD Group', 'description': "Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection", 'interventionNames': ['Drug: Collagenase Clostridium Histolyticum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radial Shockwave Therapy for ED Group', 'description': 'Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.', 'interventionNames': ['Device: Duolith SD1 T-TOP']}, {'type': 'EXPERIMENTAL', 'label': 'Linear Shockwave Therapy for ED Group', 'description': 'Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy', 'interventionNames': ['Device: Duolith SD1 T-TOP']}], 'interventions': [{'name': 'Collagenase Clostridium Histolyticum', 'type': 'DRUG', 'otherNames': ['Xiaflex'], 'description': 'Intralesional injection', 'armGroupLabels': ['Collagenase Clostridium Histolyticum for PD Group', 'Collagenase Clostridium Histolyticum with LiSWT for PD Group']}, {'name': 'Duolith SD1 T-TOP', 'type': 'DEVICE', 'description': 'Delivers low-intensity shockwave therapy, six sessions (once/week) of 2000 shockwaves per session with a constant energy flux density of 0.29 mJ/mm2 and frequency of 3 Hz', 'armGroupLabels': ['Collagenase Clostridium Histolyticum with LiSWT for PD Group', 'Linear Shockwave Therapy for ED Group', 'Radial Shockwave Therapy for ED Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Tobias Kohler, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tobias S. Kohler, MD, MPH', 'investigatorAffiliation': 'Mayo Clinic'}}}}