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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Initia
ClinicalTrials.gov Identifier:
NCT01811797
First received: March 13, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Vasculogenic Erectile Dysfunction
Device: Low Intensity Shockwave by Renova
Device: Sham treatment

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

Resource links provided by NLM:


Further study details as provided by Initia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment [ Time Frame: 0 and 6 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Intensity Shockwave treatment
4 weekly sessions of Low Intensity Shockwave treatment.
Device: Low Intensity Shockwave by Renova
Sham Comparator: Control group Device: Sham treatment
Sham treatment that looks, sounds and feels like the real LISW treatment.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811797

Locations
Israel
The Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Initia
  More Information

Publications:
Responsible Party: Initia
ClinicalTrials.gov Identifier: NCT01811797     History of Changes
Other Study ID Numbers: RENO-03-ICH
Study First Received: March 13, 2013
Last Updated: June 10, 2014
Health Authority: Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Initia:
Erectile Dysfunction
Extracorporeal shockwave
Low intensity shockwaves

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014