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

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.

Study Overview

• Status: Completed
• Conditions: Penile Diseases; Peyronie Disease
• Intervention / Treatment: Device: Low intensity choc waves therapy (active applicator); Device: Sham (sham applicator)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • Centre d'Urologie du Polygone
  • Nice, France, 06000
    • Hopital Pasteur 2
  • Suresnes, France, 92151
    • Foch Hospital
  • Toulouse, France, 31059
    • Hôpital Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low intensity choc waves therapy (Experimental group); The patients will use the device with a real applicator.	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 Comparator: Sham group; The patients will use the device with a sham applicator. Instead of a focusing lens, the applicator will have an internal foam piece that will dissipate the energy of the shockwave. Hence, the sham applicator will look, feel and sound the same as the active, but no measurable energy is emitted	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the safety of ESWT on patients with PD: adverse events	Treatment related adverse events recorded at each visits.	3 months
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
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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Collaborators: Dornier MedTech Systems
• Investigators: Principal Investigator: Thierry LEBRET, PhD, Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: 2019_0075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No