Skip to main content
OpenTrials
Completed

NCT Number: NCT02005731

Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction

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

Completed

Looking for future studies?

Notify Me

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

Observational

Primary location

Urologickaambulance, Brno, Czechia

Loading trial locations.

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

Low intensity linear focused shockwave device ('Renova')

Device

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 SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment

    Time frame: 1, 3 and 6 months post treatment

  2. Responses to the GAQ (Global Assessment questions) Questions 1 and 2 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 Multicenter Pilot Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

Acronym: LISW

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2013
Registry last updated
Jun 11, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.