Linear Focused Shockwave Treatment for Erectile Dysfunction
NCT ID: NCT02152683
Last Updated: 2022-08-11
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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TERMINATED
NA
84 participants
INTERVENTIONAL
2014-03-31
2015-08-31
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
NONE
Study Groups
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long protocol
Renova
Renova
Low- Intensity Shockwave
short protocol
Renova
Renova
Low- Intensity Shockwave
Interventions
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Renova
Low- Intensity Shockwave
Eligibility Criteria
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Inclusion Criteria
2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
5. Stable sexual relationship for at least 3 months prior to treatment
6. Minimum of two sexual attempts per month
Exclusion Criteria
2. Past radical prostatectomy or extensive pelvic surgery
3. Recovering from cancer during last year
4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
5. Clinically significant chronic hematological disease
6. Anti-androgens, oral or injectable androgens
7. Past radiotherapy treatment of the pelvic region
8. 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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Eastchester Center for Cancer Care
New York, New York, United States
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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LISW-NY
Identifier Type: -
Identifier Source: org_study_id
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