Trials Sponsors Conditions Drugs Pricing

Conditions

Penile Diseases Peyronie Disease

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.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (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),

Sponsors & Collaborators

Dornier MedTech Systems
Industrycollaborator
Hopital Foch
Otherlead

Study Sites (4)

Centre d'Urologie du Polygone

Montpellier, 34000, France

Hôpital Pasteur 2

Nice, 06000, France

Foch hospital

Suresnes, 92151, France

Hôpital Rangueil

Toulouse, 31059, France

MeSH Terms

Conditions

Penile IndurationPenile Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

Thierry LEBRET, PhD
Hopital Foch
PRINCIPAL INVESTIGATOR

Enrollment

120 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Low intensity choc waves therapy (Experimental group)

Sham group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Low intensity choc waves therapy (Experimental group)

Sham group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations