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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05646602
Collaborator
(none)
800
Enrollment
1
Location
4
Arms
21.1
Anticipated Duration (Months)
38
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Collagenase Clostridium Histolyticum
  • Device: Duolith SD1 T-TOP
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Collagenase Clostridium Histolyticum with LiSWT for PD Group

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

    Drug: Collagenase Clostridium Histolyticum
    Intralesional injection
    Other Names:
  • Xiaflex

    		•
    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

    Outcome Measures

    Primary Outcome Measures

    1. Change in penile curvature [Baseline, 10 weeks]

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

    Secondary Outcome Measures

    1. 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

    2. Change in penile length [Baseline, 10 weeks]

    3. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Tobias S. Kohler, MD, MPH, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05646602
    Other Study ID Numbers:
    • 22-001663
    First Posted:
    Dec 12, 2022
    Last Update Posted:
    Dec 12, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Penile Induration

    Study Results

    No Results Posted as of Dec 12, 2022