Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Peyronie Disease, Penile Curvature, Erectile Dysfunction

Intervention / Treatment
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* Drug: Collagenase Clostridium Histolyticum
* Device: Duolith SD1 T-TOP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagenase Clostridium Histolyticum with LiSWT for PD Group<br>Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT). | Drug: Collagenase Clostridium Histolyticum<br>* Intralesional injection<br>* Other names: Xiaflex;Device: Duolith SD1 T-TOP<br>* 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<br>|
| Active Comparator: Collagenase Clostridium Histolyticum for PD Group<br>Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection | Drug: Collagenase Clostridium Histolyticum<br>* Intralesional injection<br>* Other names: Xiaflex;|
| Active Comparator: Radial Shockwave Therapy for ED Group<br>Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy. | Device: Duolith SD1 T-TOP<br>* 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<br>|
| Experimental: Linear Shockwave Therapy for ED Group<br>Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy | Device: Duolith SD1 T-TOP<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in penile curvature | Measured with a goniometer after artificial erection reported in degree unit of measurements | Baseline, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |