Status:
COMPLETED
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
Lead Sponsor:
Hopital Foch
Collaborating Sponsors:
Dornier MedTech Systems
Conditions:
Peyronie Disease
Penile Diseases
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04821115
Start Date
April 6 2021
End Date
May 24 2024
Last Update
July 31 2024
Active Locations (4)
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1
Centre d'Urologie du Polygone
Montpellier, France, 34000
2
Hôpital Pasteur 2
Nice, France, 06000
3
Foch hospital
Suresnes, France, 92151
4
Hôpital Rangueil
Toulouse, France, 31059