Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction. (ESWTvsED)

Grzegorz Fojecki

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Sham treatment; Device: ESWT treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02063061

CIV-13-07-011546

Details and patient eligibility

About

The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.

Full description

Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.

Enrollment: 126 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Erectile dysfunction for at least 6 months
• In relationships
• Patient accept not to use any other therapy against erectile dysfunction

Exclusion criteria

• Prostatectomy
• Radiotherapy in pelvis
• Hormonal therapy against prostate cancer
• Anatomical penis disorder
• Penile prosthesis
• Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
• Psychiatric disorder
• Hypogonadism
• IIEF score higher than 25
• Pregnant partner og delivered within last 12 months
• Critical health disease
• Neurological disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Sham treatment

Sham Comparator group

Description:

Subject will answer standardized questionnaires. Sham treatment arm will receive initially 5 sham series and after they answer standardized questionnaires they will receive 5 series of active treatment. Afterwards patients will answer standardized questionnaires again.

Treatment:

Device: ESWT treatment

Device: Sham treatment

ESWT treatment

Active Comparator group

Description:

Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.

Treatment:

Device: ESWT treatment