Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction
NCT ID: NCT02005731
Last Updated: 2014-06-11
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
58 participants
OBSERVATIONAL
2012-11-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Shockwaves
Low intensity linear focused shockwave device ('Renova')
Low intensity linear focused shockwave device ('Renova')
Interventions
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Low intensity linear focused shockwave device ('Renova')
Eligibility Criteria
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Inclusion Criteria
* Vasculogenic ED for at least 6 months
* International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
* Positive response to PDE5-I (able to penetrate on demand, Responders)
* Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
* Stable heterosexual relationship for more than 3 months
Exclusion Criteria
* Neurological pathology
* Hormonal pathology
* Past radical prostatectomy
* Recovering from cancer during last 5 years
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical - abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region
20 Years
80 Years
MALE
No
Sponsors
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Initia
INDUSTRY
Responsible Party
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Principal Investigators
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Cobi Reisman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands
Locations
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Urologickaambulance
Brno, , Czechia
Amber Clinic
Klaipėda, , Lithuania
Men's Health Clinic, Amstelland Hospital
Amsterdam, , Netherlands
Urology and Andrology Center, Red Crescent Hospital (RCH)
Ramallah, , Palestinian Territories
Countries
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References
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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.
Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
Other Identifiers
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LSWT-004-EU
Identifier Type: -
Identifier Source: org_study_id
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