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Low Intensity Extracorporeal Shockwave Therapy 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: Low intensity linear focused shockwave device ('Renova') (Device)

Phase: N/A

Status: Completed

Sponsored by: Initia

Official(s) and/or principal investigator(s):
Cobi Reisman, MD, PhD, Principal Investigator, Affiliation: Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

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 SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment

Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment

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

Urologickaambulance, Brno, Czech Republic

Amber Clinic, KlaipÄ—da, Lithuania

Men's Health Clinic, Amstelland Hospital, Amsterdam, Netherlands

Urology and Andrology Center, Red Crescent Hospital (RCH), Ramallah, Palestinian Territories, Occupied

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: November 2012
Last updated: June 10, 2014

Page last updated: August 23, 2015

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