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No participants enrolled
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagenase Clostridium Histolyticum with LiSWT for PD Group | Experimental | Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT). |
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| Collagenase Clostridium Histolyticum for PD Group | Active Comparator | Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection |
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| Radial Shockwave Therapy for ED Group | Active Comparator | Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy. |
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| Linear Shockwave Therapy for ED Group | Experimental | Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum | Drug | Intralesional injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in penile curvature | Measured with a goniometer after artificial erection reported in degree unit of measurements | Baseline, 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual function | 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 | Baseline, 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kohler, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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
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| Duolith SD1 T-TOP | Device | 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 |
|
| Change in penile length | Baseline, 10 weeks |
| Li-SWL related pain at therapy sessions | Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain) | 6 weeks |
| D052801 |
| Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |