Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT02063061
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2014-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
Sponsor:
Grzegorz Fojecki
Organization:
Study Overview
Official Title:
Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESWTvsED
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: