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Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction (LISW)

I

Initia

Status

Completed

Conditions

Vasculogenic Erectile Dysfunction

Treatments

Device: Low intensity linear focused shockwave device ('Renova')

Study type

Observational

Funder types

Industry

Identifiers

NCT02005731
LSWT-004-EU

Details and patient eligibility

About

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

Enrollment

58 patients

Sex

Male

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

58 participants in 1 patient group

Shockwaves
Description:
Low intensity linear focused shockwave device ('Renova')
Treatment:
Device: Low intensity linear focused shockwave device ('Renova')

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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