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

NCT04821115 | Completed

• 1 other identifier: 2019_0075
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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 be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.

Conditions

Peyronie Disease; Penile Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of the safety of ESWT on patients with PD: adverse events

  3 months

• Assessment of the effect of ESWT on penile pain

  3 months

• Assessment of the effect of ESWT on sexual bother

  3 months

Study Arms (2)

Low intensity choc waves therapy (Experimental group)

EXPERIMENTAL

The patients will use the device with a real applicator.

Device: Low intensity choc waves therapy (active applicator)

Sham group

SHAM COMPARATOR

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)

Interventions

Low intensity choc waves therapy (active applicator) DEVICE

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.

Low intensity choc waves therapy (Experimental group)

Sham (sham applicator) DEVICE

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.

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead
• Dornier MedTech Systems: collaborator

Study Sites (4)

Centre d'Urologie du Polygone

Montpellier, 34000, France

Location

Hôpital Pasteur 2

Nice, 06000, France

Location

Foch hospital

Suresnes, 92151, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Penile Induration; Penile Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thierry LEBRET, PhD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: April 6, 2021
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)