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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: Sham treatment; Device: ESWT treatment

• Registration Number: NCT02063061
• Lead Sponsor: Grzegorz Fojecki

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-01-09
• Study Start: 2014-02
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2014-08
• Study Completion: 2015-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham treatment	Sham treatment	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.
Sham treatment	ESWT treatment	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.
ESWT treatment	ESWT treatment	Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF) outcome increases by 5 points	1 year

Secondary Outcome Measures

Name	Time	Method
Erectile Hardness Scale (EHS) outcome is equal or higher than 3.	1 year

Trial Locations

Locations (1)

Hospital of Southern Denmark; 🇩🇰 Sonderborg, Southern Denmark, Denmark