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Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

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: Low Intensity Shockwave by Renova (Device); Sham treatment (Device)

Phase: N/A

Status: Terminated

Sponsored by: Initia

Summary

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy

(LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the

control sham patients.

Clinical Details

Official title: A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment

Secondary outcome:

Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment

Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment

Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment

Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment

Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment

Eligibility

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

Criteria:

Inclusion Criteria:

- Good general health

- 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:

- Hormonal, neurological or psychological pathology

- 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)

Locations and Contacts

The Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
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.

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. 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: October 2013
Last updated: May 11, 2015

Page last updated: August 23, 2015

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