Peyronie DiseaseONDELANCT04821115
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
A study testing Low intensity choc waves therapy (active applicator) in people with Peyronie Disease and Penile Diseases, run by Hopital Foch at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie Disease, Penile Diseases
- What is being tested?
- Low intensity choc waves therapy (active applicator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Apr 2021to 24 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre d'Urologie du Polygone
Montpellier, 34000
Hôpital Pasteur 2
Nice, 06000
Foch hospital
Suresnes, 92151
Hôpital Rangueil
Toulouse, 31059
About this study
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
- Being tested
- Low intensity choc waves therapy (active applicator), Sham (sham applicator)
- Medical subject headings
- Penile Induration, Penile Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity choc waves therapy (Experimental group) | Experimental | The patients will use the device with a real applicator. Receives: 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 Receives: Device: Sham (sham applicator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 months
Secondary outcomes (3)
Assessment of the safety of ESWT on patients with PD: adverse events
Treatment related adverse events recorded at each visits.
Measured: 3 months
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
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start6 Apr 2021
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Dornier MedTech Systems
- Responsible party
- Sponsor
- Investigators
- Thierry LEBRET, PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821115
- Sponsor's protocol ID
- 2019_0075
- Acronym
- ONDELA
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
- ClinicalTrials.gov ID
- NCT04821115
- Acronym / sponsor ID
- ONDELA / 2019_0075
- Conditions
- Peyronie Disease, Penile Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Dornier MedTech Systems
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity choc waves therapy (Experimental group) | Experimental | Device: Low intensity choc waves therapy (active applicator)The patients will use the device with a real applicator. |
| Sham group | Sham comparator | Device: Sham (sham 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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,
Key exclusion criteria (14 listed)
- Congenital penile deformity,
- Hourglass deformity,
- Circumferential plaque,
- Septal or ventral plaque,
- Plaque that cannot be palpated during clinical examination,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Low intensity choc waves therapy (Experimental group) |
| 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. | Device | Sham group |
Primary outcome
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
3 secondary outcomes
Assessment of the safety of ESWT on patients with PD: adverse events
Time frame: 3 months
Assessment of the effect of ESWT on penile pain
Time frame: 3 months
Assessment of the effect of ESWT on sexual bother
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry LEBRET, PhD principal investigator
Hopital Foch
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity choc waves therapy (active applicator) in people with Peyronie Disease and Penile Diseases, run by Hopital Foch at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.