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

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

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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