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

NCT04821115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-31

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Dornier MedTech Systems

    collaborator INDUSTRY

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Thierry LEBRET, PhD · Hopital Foch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2024-05-24
Completion
2024-05-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821115 on ClinicalTrials.gov