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
Overview
- Phase
- Not Applicable
- Intervention
- Collagenase Clostridium Histolyticum
- Conditions
- Peyronie Disease
- Sponsor
- Mayo Clinic
- Locations
- 1
- Primary Endpoint
- Change in penile curvature
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
Tobias S. Kohler, MD, MPH
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
Arms & Interventions
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).
Intervention: Collagenase Clostridium Histolyticum
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).
Intervention: Duolith SD1 T-TOP
Collagenase Clostridium Histolyticum for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection
Intervention: Collagenase Clostridium Histolyticum
Radial Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
Intervention: Duolith SD1 T-TOP
Linear Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy
Intervention: Duolith SD1 T-TOP
Outcomes
Primary Outcomes
Change in penile curvature
Time Frame: Baseline, 10 weeks
Measured with a goniometer after artificial erection reported in degree unit of measurements
Secondary Outcomes
- Change in penile length(Baseline, 10 weeks)
- Change in Sexual function(Baseline, 10 weeks)
- Li-SWL related pain at therapy sessions(6 weeks)