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Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders (LI-ESWT)

R

Rambam Health Care Campus

Status and phase

Unknown
Phase 3

Conditions

Erectile Dysfunction

Treatments

Device: "MEDISPEC" treatment probe

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01274923
0200-09-rmb europe

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. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

Enrollment

20 estimated 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

20 participants in 2 patient groups

shock wave treatment
Sham Comparator group
Treatment:
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: "MEDISPEC" treatment probe

Trial contacts and locations

1

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Central trial contact

Yoram Gruenwald, Prof; Ilan Gruenwald, MD

Data sourced from clinicaltrials.gov

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