[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521118":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":32,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":32,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":32,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy","EXPERIMENTAL","Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).",[13,14],"Drug: Collagenase Clostridium Histolyticum","Device: Storz Duolith LiSWT",{"label":16,"type":17,"description":18,"interventionNames":19},"Collagenase Clostridium Histolyticum","ACTIVE_COMPARATOR","Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.",[13],[21,27],{"type":22,"name":16,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Total of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart.",[16,9],[26],"Xiaflex",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Storz Duolith LiSWT","Single low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks\u002Fminute and using a power setting of 0.09 mJ\u002Fmm2. These treatments will occur four separate times, before each of the four separate CCH injection series.",[9],null,[34],{"name":35,"affiliation":5,"role":36},"Tobias Kohler, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Wyatt H Anians, CCRP","CONTACT","507-538-6151","Anians.Wyatt@mayo.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Mayo Clinic Minnesota","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-92.4699,44.02163,{"lat":56,"lon":55},[59],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Tobias S. Kohler, MD, MPH","Principal Investigator","100521118","concurrent-low-intensity-shockwave-therapy-on-collagenase-clostridium-histolyticum-for-peyronies-disease-100521118",false,"NCT06065436","Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease","Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial","Inclusion Criteria\n\n• Diagnosed with PD\n\n* Palpable penile plaque\n* Dorsal, lateral, or dorsolateral penile curvature\n* Penile curvature \\> 30 degrees and \\\u003C 90 degrees as measured using goniometer during objective curvature assessment\n* Non-calcified plaque or grade 1 calcification (\"stippling\", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)\n* \"Stable PD symptoms' defined as PD symptom duration \\> 6-months or stable symptoms \\> 3-months\n\nExclusion Criteria:\n\n* Prior intralesional injections or surgery for PD.\n* Severe baseline penile pain.\n* Moderate or severe baseline ED based on IIEF-EF domain.\n* History of low intensity shockwave therapy for sexual dysfunction (ED or PD).\n* Ventral (downward) or ventrolateral penile curvature.\n* Moderate or severe (grade 2\u002F3) plaque calcification as determined by PDDU.\n* Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.","MALE","18 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.",[80,81],"Peyronie Disease","Erectile Dysfunction","2026-01-05",{"date":84,"type":85},"2026-01-07","ACTUAL",{"date":87,"type":85},"2024-01-19",{"date":89,"type":74},"2027-01",{"name":5,"class":6},1]