Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction
NCT ID: NCT05646602
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-03-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Collagenase Clostridium Histolyticum with LiSWT for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).
Collagenase Clostridium Histolyticum
Intralesional injection
Duolith SD1 T-TOP
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
Collagenase Clostridium Histolyticum for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection
Collagenase Clostridium Histolyticum
Intralesional injection
Radial Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
Duolith SD1 T-TOP
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
Linear Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy
Duolith SD1 T-TOP
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
Interventions
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Collagenase Clostridium Histolyticum
Intralesional injection
Duolith SD1 T-TOP
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The presence of penile plaque or pain at erection or curvature
* PD therapy with or without simultaneous intralesional Xiaflex injection.
Exclusion Criteria
* Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections.
* Unwillingness or inability to provide informed consent.
* Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Tobias S. Kohler, MD, MPH
Principal Investigator
Principal Investigators
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Tobias Kohler, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-001663
Identifier Type: -
Identifier Source: org_study_id
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