An interventional study of Sham treatment and ESWT treatment in Erectile Dysfunction, sponsored by Grzegorz Fojecki. Completed at 1 site in Denmark. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by Grzegorz Fojecki · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 126 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →This is the only study on the registry with Grzegorz Fojecki as lead sponsor.
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Exclusion Criteria:
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.
Device: Sham treatment · Device: ESWT treatment
Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.
Device: ESWT treatment
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.
Also known as: Sham
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Also known as: ESWT
International Index of Erectile Function (IIEF) outcome increases by 5 points
Time frame: 1 year
Erectile Hardness Scale (EHS) outcome is equal or higher than 3.
Time frame: 1 year
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome
Assesed after complition af clinical trial
Time frame: 18 weeks
Number of Participants with Adverse Events
During treatment period all patients will be examined for advers events
Time frame: 18 weeks
Plan to share: No
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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