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

Not Applicable

Completed

• Conditions: Peyronie Disease; Penile Diseases
• Interventions: Device: Sham (sham applicator); Device: Low intensity choc waves therapy (active applicator)

• Registration Number: NCT04821115
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Study Start: 2021-04-06
• Primary Completion: 2024-05-24
• Study Completion: 2024-05-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	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
Low intensity choc waves therapy (Experimental group)	Low intensity choc waves therapy (active applicator)	The patients will use the device with a real applicator.

Primary Outcome Measures

Name	Time	Method
Effect of low intensity ESWT on penile curvature in erection in patients with Peyronie's disease	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

Secondary Outcome Measures

Name	Time	Method
Assessment of the safety of ESWT on patients with PD: adverse events	3 months	Treatment related adverse events recorded at each visits.
Assessment of the effect of ESWT on penile pain	3 months	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	3 months	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.

Trial Locations

Locations (4)

Foch hospital; 🇫🇷 Suresnes, France

Hôpital Pasteur 2; 🇫🇷 Nice, France

Hôpital Rangueil; 🇫🇷 Toulouse, France

Centre d'Urologie du Polygone; 🇫🇷 Montpellier, France