Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction
Status
Withdrawn
Conditions
Erectile Dysfunction
Penile Curvature
Peyronie Disease
Treatments
Device: Duolith SD1 T-TOP
Drug: Collagenase Clostridium Histolyticum
Details and patient eligibility
About
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).
Sex
Male
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Peyronie's Disease (PD) at any stage
- The presence of penile plaque or pain at erection or curvature
- PD therapy with or without simultaneous intralesional Xiaflex injection.
Exclusion criteria
- Prior penile surgery or LiSWT.
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
0 participants in 4 patient groups
Collagenase Clostridium Histolyticum with LiSWT for PD Group
Experimental 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).
Treatment:
Drug: Collagenase Clostridium Histolyticum
Device: Duolith SD1 T-TOP
Collagenase Clostridium Histolyticum for PD Group
Active Comparator group
Description:
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection
Treatment:
Drug: Collagenase Clostridium Histolyticum
Radial Shockwave Therapy for ED Group
Active Comparator group
Description:
Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
Treatment:
Device: Duolith SD1 T-TOP
Linear Shockwave Therapy for ED Group
Experimental group
Description:
Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy
Treatment:
Device: Duolith SD1 T-TOP
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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