Overview

This trial is active, not recruiting.

Condition erectile dysfunction
Treatments sham treatment, eswt treatment
Sponsor Grzegorz Fojecki
Collaborator University of Southern Denmark
Start date February 2014
End date August 2014
Trial size 126 participants
Trial identifier NCT02063061, CIV-13-07-011546

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Sham Comparator)
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 Sham
Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.
eswt treatment ESWT
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
(Active Comparator)
Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.
eswt treatment ESWT
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.

Primary Outcomes

Measure
International Index of Erectile Function (IIEF) outcome increases by 5 points
time frame: 1 year

Secondary Outcomes

Measure
Erectile Hardness Scale (EHS) outcome is equal or higher than 3.
time frame: 1 year

Eligibility Criteria

Male participants at least 40 years old.

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

Additional Information

Official title Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Southern Denmark.