Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 12, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJanuary 25, 2011
November 1, 2010
1.3 years
May 12, 2009
January 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IIEF score
3 months
Secondary Outcomes (5)
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
Study Arms (1)
Treated Group
ACTIVE COMPARATORThis group will receive actual shockwave treatment
Interventions
Energy Density - 0.02 - 0.15 mJ/mm2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medispeclead
- Rambam Health Care Campuscollaborator
Study Sites (1)
Rambam Medical Center
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoram Vardi, Professor
Rambam Health Care Campus
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 12, 2009
First Posted
May 13, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
January 25, 2011
Record last verified: 2010-11