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

Vasculogenic Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01811797
• Other study ID #: RENO-03-ICH
• Status: Terminated
• Phase: N/A
• First received: March 13, 2013
• Last updated: May 11, 2015
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Initia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthIsrael: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Vasculogenic Erectile Dysfunction

Intervention

Device:
• Low Intensity Shockwave by Renova

• Sham treatment
Sham treatment that looks, sounds and feels like the real LISW treatment.

Locations

Country	Name	City	State
Israel	The Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Initia

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment		1, 3 and 6 months post treatment	No
Secondary	Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment		1, 3 and 6 months post treatment	No
Secondary	Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment		1, 3 and 6 months post treatment	No
Secondary	Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment		1, 3 and 6 months post treatment	No
Secondary	Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment		1, 3 and 6 months post treatment	No
Secondary	Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment		0 and 6 months post treatment	No