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

Phase 3

• Conditions: Erectile Dysfunction
• Interventions: Device: Extracorporeal Shockwave Therapy Generator (Vascuspec); Device: Low intensity shock wave therapy

• Registration Number: NCT01262157
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-05
• Study First Submitted: 2010-07-11
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-17
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19
• Primary Completion: 2011-12
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Extracorporeal Shockwave Therapy Generator (Vascuspec)	We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Shock wave therapy	Low intensity shock wave therapy	12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment

Primary Outcome Measures

Name	Time	Method
IIEF-ED Domain	17 weeks	A change of 5 points or more will indicate success

Secondary Outcome Measures

Name	Time	Method
rigidity score	17 weeks	a scale of 3 and above indicates success

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel