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

• ClinicalTrials.gov Identifier: NCT01811797
• Recruitment Status: Terminated
• First Posted: March 15, 2013
• Last Update Posted: May 12, 2015
• Sponsor: Initia
• Information provided by (Responsible Party): Initia

Tracking Information

• First Submitted Date: March 13, 2013
• First Posted Date: March 15, 2013
• Last Update Posted Date: May 12, 2015
• Study Start Date: October 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 14, 2013): Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 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: March 14, 2013)

• Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
• Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
• Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
• Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
• Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment [ Time Frame: 0 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: Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Vasculogenic Erectile Dysfunction

Intervention

• Device: Low Intensity Shockwave by Renova
• Device: Sham treatment
  Sham treatment that looks, sounds and feels like the real LISW treatment.

Study Arms

• Experimental: Low Intensity Shockwave treatment
  4 weekly sessions of Low Intensity Shockwave treatment.
  Intervention: Device: Low Intensity Shockwave by Renova
• Sham Comparator: Control group
  Intervention: Device: Sham treatment

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.
• 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.
• 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: Terminated
• Actual Enrollment (submitted: May 11, 2015): 2
• Original Estimated Enrollment (submitted: March 14, 2013): 40
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

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: Israel

Administrative Information

• NCT Number: NCT01811797
• Other Study ID Numbers: RENO-03-ICH
• 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: Not Provided
• PRS Account: Initia
• Verification Date: May 2015