Clinical trial NCT02063061: Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
Official title: Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: extracorporeal shock wave therapy ESWT
erectile dysfunction
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region of Southern Denmark
First posted: 2014-02-14
Enrollment: 126
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Index of Erectile Function (IIEF) outcome increases by 5 points
timeFrame: 1 year
Secondary outcomes:
measure: Erectile Hardness Scale (EHS) outcome is equal or higher than 3.
timeFrame: 1 year
Other outcomes:
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome
timeFrame: 18 weeks
measure: Number of Participants with Adverse Events
timeFrame: 18 weeks
Locations:
city: Sonderborg
country: Denmark
facility: Hospital of Southern Denmark
state: Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Palle Oshter, professor
role: STUDY_DIRECTOR
References:
citation: Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013 Apr;5(2):95-9. doi: 10.1177/1756287212470696.
citation: Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.
citation: Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.