Back to results

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

Primary Purpose

Peyronie Disease, Penile Curvature, Erectile Dysfunction

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Collagenase Clostridium Histolyticum

Duolith SD1 T-TOP

About this trial

This is an interventional treatment trial for Peyronie Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Collagenase Clostridium Histolyticum with LiSWT for PD Group

Collagenase Clostridium Histolyticum for PD Group

Radial Shockwave Therapy for ED Group

Linear Shockwave Therapy for ED Group

Arm Description

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection

Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.

Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy

Outcomes

Primary Outcome Measures

Change in penile curvature

Measured with a goniometer after artificial erection reported in degree unit of measurements

Secondary Outcome Measures

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

Change in penile length

Li-SWL related pain at therapy sessions

Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)

Full Information

NCT ID

NCT05646602

First Posted

December 2, 2022

Last Updated

October 5, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05646602

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Withdrawn

Why Stopped

No participants enrolled

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peyronie Disease, Penile Curvature, Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collagenase Clostridium Histolyticum with LiSWT for PD Group

Arm Type

Experimental

Arm Description

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection with focused low-intensity shockwave therapy (LiSWT).

Arm Title

Collagenase Clostridium Histolyticum for PD Group

Arm Type

Active Comparator

Arm Description

Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection

Arm Title

Radial Shockwave Therapy for ED Group

Arm Type

Active Comparator

Arm Description

Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.

Arm Title

Linear Shockwave Therapy for ED Group

Arm Type

Experimental

Arm Description

Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy

Intervention Type

Drug

Intervention Name(s)

Collagenase Clostridium Histolyticum

Other Intervention Name(s)

Xiaflex

Intervention Description

Intralesional injection

Intervention Type

Device

Intervention Name(s)

Duolith SD1 T-TOP

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in penile curvature

Description

Measured with a goniometer after artificial erection reported in degree unit of measurements

Time Frame

Baseline, 10 weeks

Secondary Outcome Measure Information:

Title

Change in Sexual function

Description

Time Frame

Baseline, 10 weeks

Title

Change in penile length

Time Frame

Baseline, 10 weeks

Title

Li-SWL related pain at therapy sessions

Description

Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)

Time Frame

6 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tobias Kohler, MD, MPH

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs