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

NCT05646602 — Not applicable, Withdrawn, Mayo Clinic

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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

Registry	NCT05646602
Status	Withdrawn - No participants enrolled
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Sponsor	Mayo Clinic (Other)
Conditions	Peyronie Disease, Penile Curvature, Erectile Dysfunction
Interventions	Collagenase Clostridium Histolyticum, Duolith SD1 T-TOP (Drug, device)
Dates	start 2023-03-01 (estimated), primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2022-12-12, last updated 2023-10-10
Locations	1 site in United States

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Collagenase Clostridium Histolyticum with LiSWT for PD Group	Experimental	Drug: Collagenase Clostridium Histolyticum; Device: Duolith SD1 T-TOP	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 for PD Group	Active comparator	Drug: Collagenase Clostridium Histolyticum	Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection
Radial Shockwave Therapy for ED Group	Active comparator	Device: Duolith SD1 T-TOP	Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
Linear Shockwave Therapy for ED Group	Experimental	Device: Duolith SD1 T-TOP	Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy

Collagenase Clostridium Histolyticum (Drug), also known as Xiaflex: Intralesional injection
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

+Outcome measures

Primary outcomes

Change in penile curvature [Baseline, 10 weeks]: Measured with a goniometer after artificial erection reported in degree unit of measurements

Secondary outcomes

Change in Sexual function [Baseline, 10 weeks]: 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
Change in penile length [Baseline, 10 weeks]
Li-SWL related pain at therapy sessions [6 weeks]: Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)

+Eligibility

Sex: Male, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States

+Investigators

Tobias Kohler, MD, MPH, Principal investigator, Mayo Clinic