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

Peyronie Disease Clinical Trial

— ONDELA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821115
• Other study ID #: 2019_0075
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: Hopital Foch
• Contact: Thierry LEBRET, PhD
• Phone: 0146252431
• Email: t.lebret[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Penile Diseases
• Penile Induration
• Peyronie Disease

Intervention

Device:
• Low intensity choc waves therapy (active applicator)
At each of the 4 sessions, 4000 shockwaves will be delivered at level 8 (EFD = 0.133 mJ/mm2), over a period of 15 to 20 minutes. The probe will be applied directly to the plaque, on the flaccid penis. The device will stop automatically after the 4000 shock waves.
• Sham (sham applicator)
At each of the 4 sessions, a sham applicator will be used. The sham applicator has an internal foam pad that disperses the shockwave energy, but is not visible from the outside. The sham applicator will look, feel and sound the same as the active, but no measurable energy is emitted.

Locations

Country	Name	City	State
France	Centre d'Urologie du Polygone	Montpellier
France	Hôpital Pasteur 2	Nice
France	Foch hospital	Suresnes
France	Hôpital Rangueil	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Foch	Dornier MedTech Systems

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease	Average change in penile curvature based on the pictures taken by the patient (face and profil) at baseline and after the 6 week follow-up.; The assessment will be performed by a blinded assessor at the end of the study	15 months
Secondary	Assessment of the safety of ESWT on patients with PD: adverse events	Treatment related adverse events recorded at each visits.	3 months
Secondary	Assessment of the effect of ESWT on penile pain	Patient complete at each visit a numeric rating scale of penile pain graduated from 0 (no pain) to 10 (worst pain) 0 means the patient has no pain and 10 for worst pain	3 months
Secondary	Assessment of the effect of ESWT on sexual bother	Difference of the score of the International Index of Erectile Function (IIEF-5) reported by the patient at baseline and after 6 week follow-up.; The score is calculated through 5 questions with answers ranging from 0 to 5. Between 26 and 30, the score indicates no erectile dysfunction. Between 17 and 25, it indicates mild dysfunction. Between 11 and 16, it indicates a moderate dysfunction and below 10 a complete or severe dysfunction.	3 months