Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction (Penile LiSWT)

October 5, 2023 updated by: Tobias S. Kohler, MD, MPH, Mayo Clinic

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radial Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have radial shockwave therapy.
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
Experimental: Linear Shockwave Therapy for ED Group
Subjects being treated for erectile dysfunction (ED) will have linear shockwave therapy
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
Experimental: 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).
Drug: Collagenase Clostridium Histolyticum
Intralesional injection
Other Names:
  • Xiaflex
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
Active Comparator: Collagenase Clostridium Histolyticum for PD Group
Subjects being treated for Peyronie's disease (PD) will have Collagenase Clostridium Histolyticum (CCH) intralesional injection
Drug: Collagenase Clostridium Histolyticum
Intralesional injection
Other Names:
  • Xiaflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in penile curvature
Time Frame: Baseline, 10 weeks
Measured with a goniometer after artificial erection reported in degree unit of measurements
Baseline, 10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Tobias Kohler, MD, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-001663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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