Skip to main content
OpenTrials
Completed

NCT Number: NCT04821115

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peyronie Disease Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Penile Induration Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Urologie du Polygone, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease

    Time frame: 15 months

    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

Secondary outcomes

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

    Time frame: 3 months

    Treatment related adverse events recorded at each visits.

  2. Assessment of the effect of ESWT on penile pain

    Time frame: 3 months

    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. Assessment of the effect of ESWT on sexual bother

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Collaborators

  • Dornier MedTech Systems

Registry information

Acronym: ONDELA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.