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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
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: 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
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on November 24, 2014