Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)

Rambam Health Care Campus

Status and phase: Unknown; Phase 3

Conditions: Erectile Dysfunction

Treatments: Device: Omnispec model ED1000; Device: Sham control

Study type: Interventional

Funder types: Other

Identifiers

NCT01317680

0037-11-RMB

Details and patient eligibility

About

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prior prostatectomy surgery
• ED of more than 6 months
• Rigidity score < 3 during PDE5i therapy
• Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion criteria

• 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, including a placebo group

Treatment LI-ESWT

Active Comparator group

Description:

Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Treatment:

Device: Omnispec model ED1000

Sham control

Placebo Comparator group

Description:

We use the same probe that induces the same sensation on the penis and the same noise yet no energy.

Treatment:

Device: Sham control