Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction

Vasculogenic Erectile Dysfunction Clinical Trial

— LISW  

Official title:

A Prospective Multicenter Pilot Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005731
• Other study ID #: LSWT-004-EU
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: June 10, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2014
• Source: Initia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Vasculogenic Erectile Dysfunction

Intervention

Device:
• Low intensity linear focused shockwave device ('Renova')

Locations

Country	Name	City	State
Czech Republic	Urologickaambulance	Brno
Lithuania	Amber Clinic	Klaipeda
Netherlands	Men's Health Clinic, Amstelland Hospital	Amsterdam
Palestinian Territories, Occupie	Urology and Andrology Center, Red Crescent Hospital (RCH)	Ramallah

Sponsors (1)

Lead Sponsor	Collaborator
Initia

Countries where clinical trial is conducted

Czech Republic,  Lithuania,  Netherlands,  Palestinian Territories, Occupie, 

References & Publications (4)

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. — View Citation

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

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 1, 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 1, 3 and 6 months post treatment		1, 3 and 6 months post treatment	No
Secondary	Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment		1, 3 and 6 months post treatment	No