Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
NCT ID: NCT01811797
Last Updated: 2015-05-12
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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TERMINATED
NA
2 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low Intensity Shockwave treatment
4 weekly sessions of Low Intensity Shockwave treatment.
Low Intensity Shockwave by Renova
Control group
Sham treatment
Sham treatment that looks, sounds and feels like the real LISW treatment.
Interventions
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Low Intensity Shockwave by Renova
Sham treatment
Sham treatment that looks, sounds and feels like the real LISW treatment.
Eligibility Criteria
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Inclusion Criteria
* Vascular 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
* Past radical prostatectomy or extensive pelvic surgery
* 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
* Past radiotherapy treatment of the pelvic region
* International normalized ratio (INR) \> 3 for patients using blood thinners (such as Coumadin)
20 Years
80 Years
MALE
No
Sponsors
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Initia
INDUSTRY
Responsible Party
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Locations
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The Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
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.
Vardi Y, Appel B, Kilchevsky A, Gruenwald I. 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. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
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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RENO-03-ICH
Identifier Type: -
Identifier Source: org_study_id
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