Back to resultsLow Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study (LI-ESWT)
Primary Purpose
Erectile Dysfunction
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Extracorporeal Shockwave Therapy Generator (Vascuspec)
Low intensity shock wave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, PDE5 Inhibitor, Low intensity shock wave therapy.
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
Sites / Locations
- Rambam Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
placebo
Shock wave therapy
Arm Description
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
Outcomes
Primary Outcome Measures
IIEF-ED Domain
A change of 5 points or more will indicate success
Secondary Outcome Measures
rigidity score
a scale of 3 and above indicates success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01262157
Brief Title
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
Acronym
LI-ESWT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, PDE5 Inhibitor, Low intensity shock wave therapy.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Arm Title
Shock wave therapy
Arm Type
Active Comparator
Arm Description
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shockwave Therapy Generator (Vascuspec)
Other Intervention Name(s)
Low intensity shock wave Therapy, Extracorporeal Shockwave Therapy
Intervention Description
Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Intervention Type
Device
Intervention Name(s)
Low intensity shock wave therapy
Other Intervention Name(s)
Low Intensity Extra Corporal Shock Wave Therapy
Intervention Description
Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Primary Outcome Measure Information:
Title
IIEF-ED Domain
Description
A change of 5 points or more will indicate success
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
rigidity score
Description
a scale of 3 and above indicates success
Time Frame
17 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoram Vardi, Prof
Phone
++97248542819
Email
yvardi@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Gruenwald, MD
Phone
++97248542819
Email
i_gruenwald@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, prof
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, Prof
Phone
++97248542819
Email
yvardi@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
First Name & Middle Initial & Last Name & Degree
Boaz Appel, MD
12. IPD Sharing Statement
Learn more about this trial
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
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