DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Linear Focused Shockwave Treatment for Erectile Dysfunction

Information source: Initia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasculogenic Erectile Dysfunction

Intervention: Renova (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Initia

Overall contact:
Karen Hoffman, MD, Phone: 718-732-4029, Email: karen@eastchestercenter.com

Summary

The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

Clinical Details

Official title: Linear Focused Shockwave Treatment for Erectile Dysfunction

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

IIEF-EF- International Index of Erectile Function questionnaire score

IIEF-EF questionnaire score

IIEF-EF questionnaire score

Secondary outcome:

SEP- Sexual Encounter Profile: Questions 2 and 3

GAQ- Global Assessment Questions

EHS- Erection Hardness Score

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. Good general health 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: 1. Hormonal, neurological or psychological pathology 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)

Locations and Contacts

Karen Hoffman, MD, Phone: 718-732-4029, Email: karen@eastchestercenter.com

Eastchester Center for Cancer Care, New york, New York 10469, United States; Recruiting
Karen Hoffman, MD, Phone: 718-732-4029, Email: karen@eastchestercenter.com
Anthony Hoffman, MD, Principal Investigator
Additional Information

Related publications:

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.

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. Review.

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.

Starting date: March 2014
Last updated: May 11, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017