Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Initia
ClinicalTrials.gov Identifier:
NCT01814852
First received: March 18, 2013
Last updated: April 6, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention
Vasculogenic Erectile Dysfunction
Device: Shockwave system
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 of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

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 1, 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 OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 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 HES (Erection Hardness Score) at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shockwaves
4 weekly sessions of low-intensity shockwave therapy
Device: Shockwave system
Other Name: Renova
Sham Comparator: Control Group Device: Sham treatment
Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.

Detailed Description:

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814852

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Initia
Investigators
Principal Investigator: Uri Gur, M.D.
  More Information

Publications:
Responsible Party: Initia
ClinicalTrials.gov Identifier: NCT01814852     History of Changes
Other Study ID Numbers: RENO-006B-MR
Study First Received: March 18, 2013
Last Updated: April 6, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Initia:
Low Intensity Shockwave
Extracorporeal shockwave therapy
Erectile dysfunction

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 April 16, 2014