Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
NCT ID: NCT02063061
Last Updated: 2016-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2014-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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 treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
ESWT treatment
Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.
ESWT treatment
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Interventions
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Sham 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.
ESWT treatment
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In relationships
* Patient accept not to use any other therapy against erectile dysfunction
Exclusion Criteria
* 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
40 Years
MALE
No
Sponsors
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University of Southern Denmark
OTHER
Region of Southern Denmark
OTHER
Grzegorz Fojecki
OTHER
Responsible Party
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Grzegorz Fojecki
MD
Principal Investigators
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Palle Oshter, professor
Role: STUDY_DIRECTOR
University of Southern Denmark
Locations
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Hospital of Southern Denmark
Sønderborg, Southern Denmark, Denmark
Countries
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References
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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.
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.
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.
Related Links
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regional ethical committee
University of Southern Denmark
Other Identifiers
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CIV-13-07-011546
Identifier Type: -
Identifier Source: org_study_id