Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction (LI-ESWT)
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
"MEDISPEC" treatment probe
"MEDISPEC" Sham Probe
"MEDISPEC" Low intensity shock waves
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Low Intensity Shock Wave
Eligibility Criteria
Inclusion Criteria:
- ED of more than 6 months
- Rigidity score ≥ 3 under PDE5i therapy
- SHIM ≤21 under 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
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
shock wave treatment
"MEDISPEC" Sham
Arm Description
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Outcomes
Primary Outcome Measures
International Index of Erectile function- Erectile Function Domain
An increase in score of 5points and above will be considered success.
Secondary Outcome Measures
Rigidity scale
A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success
Flow Mediated Dilatation Technique
A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.
Full Information
NCT ID
NCT01274156
First Posted
December 14, 2010
Last Updated
January 10, 2011
Sponsor
Rambam Health Care Campus
Collaborators
Medispec
1. Study Identification
Unique Protocol Identification Number
NCT01274156
Brief Title
Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction
Acronym
LI-ESWT
Official Title
The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Medispec
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.
Detailed Description
This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, Low Intensity Shock Wave
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
shock wave treatment
Arm Type
Active Comparator
Arm Title
"MEDISPEC" Sham
Arm Type
Sham Comparator
Arm Description
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Intervention Type
Device
Intervention Name(s)
"MEDISPEC" treatment probe
Other Intervention Name(s)
VASCUSPEC
Intervention Description
300 shocks in 5 different anatomical locations of the penis.
Intervention Type
Device
Intervention Name(s)
"MEDISPEC" Sham Probe
Other Intervention Name(s)
VASCUSPEC
Intervention Description
Sham probe applied same as treatment probe without energy
Intervention Type
Device
Intervention Name(s)
"MEDISPEC" Low intensity shock waves
Other Intervention Name(s)
VASCULOSPEC
Intervention Description
Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min
Intervention Type
Device
Intervention Name(s)
Sham
Other Intervention Name(s)
Vasculospec
Intervention Description
Probe does not deliver energy but creates same noise and sensation of active probe
Primary Outcome Measure Information:
Title
International Index of Erectile function- Erectile Function Domain
Description
An increase in score of 5points and above will be considered success.
Time Frame
At screening and 17 weeks later at last visit
Secondary Outcome Measure Information:
Title
Rigidity scale
Description
A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success
Time Frame
At screening and 17 weeks later at last visit
Title
Flow Mediated Dilatation Technique
Description
A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.
Time Frame
At screening and 17 weeks later at last visit
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ED of more than 6 months
Rigidity score ≥ 3 under PDE5i therapy
SHIM ≤21 under 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
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction
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