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Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With 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: Shockwave system (Device); Sham treatment (Device)

Phase: N/A

Status: Completed

Sponsored by: Initia

Official(s) and/or principal investigator(s):
Uri Gur, M.D., Principal Investigator

Summary

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Clinical Details

Official title: A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

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 1, 3 and 6 months post treatment

Secondary outcome:

Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment

Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment

Detailed description: This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1: 1 ratio of Renova to the sham control group.

Eligibility

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

Criteria:

Inclusion Criteria:

- Good general health

- 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:

- Psychogenic ED

- 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

Locations and Contacts

Meir Medical Center, Kfar Saba, 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.

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: December 2012
Last updated: May 11, 2015

Page last updated: August 23, 2015

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