Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study (LI-ESWT)

Rambam Health Care Campus

Status and phase: Unknown; Phase 3

Conditions: Erectile Dysfunction

Treatments: Device: Extracorporeal Shockwave Therapy Generator (Vascuspec); Device: Low intensity shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01262157

507-10 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 that do not respond to oral therapy (PDE-5 inhibitors).

Full description

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Enrollment: 60 estimated patients

Sex: Male

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ED of more than 6 months
• Rigidity score < 3 during PDE5i therapy
• SHIM <21 during 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: Single Group Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

placebo

Sham 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: Extracorporeal Shockwave Therapy Generator (Vascuspec)

Shock wave therapy

Active Comparator group

Description:

12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment

Treatment:

Device: Low intensity shock wave therapy