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NCT Number: NCT01814852

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

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.

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Key information

Conditions

Vasculogenic Erectile Dysfunction Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Meir Medical Center

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shockwave system

Device

Other names: Renova

Sham treatment

Device

Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Initia

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2013
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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