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

Primary Purpose

Peyronie Disease, Penile Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low intensity choc waves therapy (active applicator)
Sham (sham applicator)
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peyronie Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre d'Urologie du PolygoneRecruiting
  • Hôpital Pasteur 2Recruiting
  • Foch hospitalRecruiting
  • Hôpital RangueilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low intensity choc waves therapy (Experimental group)

Sham group

Arm Description

The patients will use the device with a real applicator.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of the safety of ESWT on patients with PD: adverse events
Treatment related adverse events recorded at each visits.
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
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.

Full Information

First Posted
March 25, 2021
Last Updated
April 26, 2022
Sponsor
Hopital Foch
Collaborators
Dornier MedTech Systems
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1. Study Identification

Unique Protocol Identification Number
NCT04821115
Brief Title
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
Acronym
ONDELA
Official Title
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
Collaborators
Dornier MedTech Systems

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie Disease, Penile Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low intensity choc waves therapy (Experimental group)
Arm Type
Experimental
Arm Description
The patients will use the device with a real applicator.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Low intensity choc waves therapy (active applicator)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham (sham applicator)
Intervention Description
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 Outcome Measure Information:
Title
Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease
Description
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
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Assessment of the safety of ESWT on patients with PD: adverse events
Description
Treatment related adverse events recorded at each visits.
Time Frame
3 months
Title
Assessment of the effect of ESWT on penile pain
Description
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
Time Frame
3 months
Title
Assessment of the effect of ESWT on sexual bother
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry LEBRET, PhD
Phone
0146252431
Ext
+33
Email
t.lebret@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar, PhD
Phone
0146251175
Ext
+33
Email
drci-promotion@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry LEBRET, PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Urologie du Polygone
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine FAIX, MD
Phone
04 67 20 21 83
Ext
+33
Email
a.faix34@gmail.com
Facility Name
Hôpital Pasteur 2
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel CHEVALLIER, PhD
Phone
04 92 03 77 87
Ext
+33
Email
chevallier.d@chu-nice.fr
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry LEBRET, PhD
Phone
0146252431
Ext
+33
Email
t.lebret@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
François-Xavier MADEC, MD
Phone
0146252111
Email
f.madec@hopital-foch.com
Facility Name
Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric HUYGHE, PhD
Phone
05 61 32 27 31
Ext
+33
Email
huyghe.e@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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