Back to resultsExtracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Extracorporeal Shockwave Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring ED, Erectile Dysfunction, Erectile dysfunction treated with PDE-5 inhibitors
Eligibility Criteria
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
Sites / Locations
- Rambam Medical Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Treated Group
Arm Description
This group will receive actual shockwave treatment
Outcomes
Primary Outcome Measures
IIEF score
Secondary Outcome Measures
Rigid Score (RS)
Quality of Erection Questionnaire (QEQ)
Self-Esteem And Relationship Questionnaire (SEAR)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)
Side Effects
Full Information
NCT ID
NCT00901056
First Posted
May 12, 2009
Last Updated
January 23, 2011
Sponsor
Medispec
Collaborators
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00901056
Brief Title
Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Official Title
Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medispec
Collaborators
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
ED, Erectile Dysfunction, Erectile dysfunction treated with PDE-5 inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated Group
Arm Type
Active Comparator
Arm Description
This group will receive actual shockwave treatment
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shockwave Therapy
Other Intervention Name(s)
Vascuspec
Intervention Description
Energy Density - 0.02 - 0.15 mJ/mm2
Primary Outcome Measure Information:
Title
IIEF score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rigid Score (RS)
Time Frame
3 months
Title
Quality of Erection Questionnaire (QEQ)
Time Frame
3 months
Title
Self-Esteem And Relationship Questionnaire (SEAR)
Time Frame
3 months
Title
Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)
Time Frame
3 months
Title
Side Effects
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, Professor
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
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