Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction (LISW)

• ClinicalTrials.gov Identifier: NCT02005731
• Recruitment Status: Completed
• First Posted: December 9, 2013
• Last Update Posted: June 11, 2014
• Sponsor: Initia
• Information provided by (Responsible Party): Initia

Tracking Information

• First Submitted Date: December 4, 2013
• First Posted Date: December 9, 2013
• Last Update Posted Date: June 11, 2014
• Study Start Date: November 2012
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 4, 2013): Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 4, 2013)

• Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment [ Time Frame: 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 [ Time Frame: 1, 3 and 6 months post treatment ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Sexual Medicine clinic
• Condition: Vasculogenic Erectile Dysfunction
• Intervention: Device: Low intensity linear focused shockwave device ('Renova')

Study Groups/Cohorts

Shockwaves

Low intensity linear focused shockwave device ('Renova')

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 4, 2013): 58
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czech Republic, Lithuania, Netherlands, Palestinian Territories, Occupied

Administrative Information

• NCT Number: NCT02005731
• Other Study ID Numbers: LSWT-004-EU
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Initia
• Study Sponsor: Initia
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cobi Reisman, MD, PhD; Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands

• PRS Account: Initia
• Verification Date: June 2014