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| Name | Class |
|---|---|
| Dornier MedTech Systems | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity choc waves therapy (Experimental group) | Experimental | The patients will use the device with a real 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety of ESWT on patients with PD: adverse events | Treatment related adverse events recorded at each visits. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry LEBRET, PhD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Urologie du Polygone | Montpellier | 34000 | France | |||
| Hôpital Pasteur 2 |
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| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D010409 | Penile Diseases |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| 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. |
|
| 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. | 3 months |
| Nice |
| 06000 |
| France |
| Foch hospital | Suresnes | 92151 | France |
| Hôpital Rangueil | Toulouse | 31059 | France |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |