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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05646602
• Other study ID #: 22-001663
• Status: Withdrawn
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Penile Curvature
• Penile Induration
• Peyronie Disease

Intervention

Drug:
• Collagenase Clostridium Histolyticum
Intralesional injection

Device:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in penile curvature	Measured with a goniometer after artificial erection reported in degree unit of measurements	Baseline, 10 weeks
Secondary	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
Secondary	Change in penile length		Baseline, 10 weeks
Secondary	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

External Links

•   Mayo Clinic Clinical Trials