ClinicalTrials.Veeva

Menu

Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction (LI-ESWT)

R

Rambam Health Care Campus

Status and phase

Completed
Phase 3

Conditions

Erectile Dysfunction

Treatments

Device: "MEDISPEC" treatment probe
Device: "MEDISPEC" Low intensity shock waves
Device: "MEDISPEC" Sham Probe
Device: Sham

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01274156
3060 RMB

Details and patient eligibility

About

This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Full description

This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.

Enrollment

60 patients

Sex

Male

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ED of more than 6 months
  • Rigidity score ≥ 3 under PDE5i therapy
  • SHIM ≤21 under PDE5i therapy
  • Non- hormonal, neurological or psychological pathology
  • Stable heterosexual relationship for more than 3 months

Exclusion criteria

  • Prior prostatectomy surgery
  • 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

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

shock wave treatment
Active Comparator group
Treatment:
Device: "MEDISPEC" Low intensity shock waves
Device: "MEDISPEC" treatment probe
"MEDISPEC" Sham
Sham Comparator group
Description:
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Treatment:
Device: Sham
Device: "MEDISPEC" Sham Probe

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems