Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

Last updated: July 30, 2024
Sponsor: Hopital Foch
Overall Status: Completed

Phase

N/A

Condition

Peyronie's Disease

Treatment

Low intensity choc waves therapy (active applicator)

Sham (sham applicator)

Clinical Study ID

NCT04821115
2019_0075
  • Ages > 18
  • Male

Study Summary

Investigation of the effect of Low-intensity extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) via a single blind, sham-controlled, randomized clinical trial. Investigators will not be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old male,

  • Untreated Peyronie's disease (excepted oral therapy) (wash out: at least 1 month),

  • Single axis penile curvature in erection at 20 - 90 degrees at baseline,

  • Dorsal or lateral penile plaque,

  • Able and willing to perform ESWT self-treatment under supervision,

  • Able to understand and complete patient questionnaires,

  • Having sign an informed consent form prior to any study specific procedure,

  • Being covered by a national health insurance

Exclusion

Exclusion Criteria:

  • Congenital penile deformity,

  • Hourglass deformity,

  • Circumferential plaque,

  • Septal or ventral plaque,

  • Plaque that cannot be palpated during clinical examination,

  • Previous intralesional injection for Peyronie's Disease,

  • Severe erectile dysfunction (EHS < 3),

  • Current penile, malignancy,

  • Previous penile surgery except for circumcision or condyloma removal,

  • Previous pelvic radiation therapy,

  • Anti-coagulant medication, except acetylsalicylic acid up to 100mg daily,

  • Previous low-intensity focused shockwave therapy on penis,

  • Any other condition that would prevent the patient from completing the study, asjudged by the principal investigator,

  • Being deprived of liberty or under guardianship.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Low intensity choc waves therapy (active applicator)
Phase:
Study Start date:
April 06, 2021
Estimated Completion Date:
May 24, 2024

Connect with a study center

  • Centre d'Urologie du Polygone

    Montpellier, 34000
    France

    Site Not Available

  • Hôpital Pasteur 2

    Nice, 06000
    France

    Site Not Available

  • Foch hospital

    Suresnes, 92151
    France

    Site Not Available

  • Hôpital Rangueil

    Toulouse, 31059
    France

    Site Not Available

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