Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Phase 1
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Device: Extracorporeal Shockwave Therapy
- Registration Number
- NCT00901056
- Lead Sponsor
- Medispec
- Brief Summary
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.
- Detailed Description
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- ED of more than 6 months
- At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
- Positive response to PDE-5 inhibitors
- IIEF-5 domain score of 12-20 denoting mild to severe ED
- Non-Neurological pathology
- Stable heterosexual relationship for more than 3 months
Exclusion Criteria
- NPT - normal/flat
- Prior prostatectomy surgery
- Any cause of ED other than vascular related
- Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Cardiovascular conditions that prevent sexual activity
- History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
- Cancer within the past 5 years.
- Anti-androgens, oral or injectable androgens
- Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated Group Extracorporeal Shockwave Therapy This group will receive actual shockwave treatment
- Primary Outcome Measures
Name Time Method IIEF score 3 months
- Secondary Outcome Measures
Name Time Method Rigid Score (RS) 3 months Quality of Erection Questionnaire (QEQ) 3 months Self-Esteem And Relationship Questionnaire (SEAR) 3 months Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT) 3 months Side Effects 3 months
Trial Locations
- Locations (1)
Rambam Medical Center
🇮🇱Haifa, Israel