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

Not Applicable

Withdrawn

• Conditions: Erectile Dysfunction; Penile Curvature; Peyronie Disease
• Interventions: Device: Duolith SD1 T-TOP; Drug: Collagenase Clostridium Histolyticum

• Registration Number: NCT05646602
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Study Start: 2023-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial Shockwave Therapy for ED Group	Duolith SD1 T-TOP	Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
Linear Shockwave Therapy for ED Group	Duolith SD1 T-TOP	Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy
Collagenase Clostridium Histolyticum with LiSWT for PD Group	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 with LiSWT for PD Group	Collagenase Clostridium Histolyticum	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	Collagenase Clostridium Histolyticum	Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection

Primary Outcome Measures

Name	Time	Method
Change in penile curvature	Baseline, 10 weeks	Measured with a goniometer after artificial erection reported in degree unit of measurements

Secondary Outcome Measures

Name	Time	Method
Change in penile length	Baseline, 10 weeks
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
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)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States