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Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

I

Initia

Status

Terminated

Conditions

Vasculogenic Erectile Dysfunction

Treatments

Device: Low Intensity Shockwave by Renova
Device: Sham treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01811797
RENO-03-ICH

Details and patient eligibility

About

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Enrollment

2 patients

Sex

Male

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Good general health
  • Vascular 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

  • Hormonal, neurological or psychological pathology
  • Past radical prostatectomy or extensive pelvic surgery
  • 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
  • Past radiotherapy treatment of the pelvic region
  • International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2 participants in 2 patient groups

Low Intensity Shockwave treatment
Experimental group
Description:
4 weekly sessions of Low Intensity Shockwave treatment.
Treatment:
Device: Low Intensity Shockwave by Renova
Control group
Sham Comparator group
Treatment:
Device: Sham treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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