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

  • End date
    Mar 16, 2023
  • participants needed
  • sponsor
    Hopital Foch
Updated on 16 May 2022


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.

Condition Peyronie Disease, Penile Diseases
Treatment Low intensity choc waves therapy (active applicator), Sham (sham applicator)
Clinical Study IdentifierNCT04821115
SponsorHopital Foch
Last Modified on16 May 2022


Yes No Not Sure

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 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, as judged by the principal investigator
Being deprived of liberty or under guardianship
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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