A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- IIEF-ED Domain
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
IIEF-ED Domain
Time Frame: 17 weeks
A change of 5 points or more will indicate success
Secondary Outcomes
- rigidity score(17 weeks)