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

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

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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