The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders (LI-ESWT)
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
LI-ESWT
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring LI-ESWT, Erectile Dysfunction, Non PDE5 inhibitor responders, Shock wave
Eligibility Criteria
Inclusion Criteria:
- ED of more than 6 months
- Rigidity score ≤ 2 during PDE5i therapy
- Stable heterosexual relationship for more than 3 months
- Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .
Exclusion Criteria:
- Prior surgery or radiotherapy in pelvic region
- Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Cardiovascular conditions that prevent sexual activity
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LI-ESWT
Arm Description
Low intensity shock wave treatment- 12 sessions
Outcomes
Primary Outcome Measures
IIEF-ED Domain score
Change of 5 points and above in IIEF-ED Domain score
Secondary Outcome Measures
rigidity scale
a change to 3 or 4 points in the rigidty scale
Full Information
NCT ID
NCT01272297
First Posted
December 14, 2010
Last Updated
December 18, 2012
Sponsor
Rambam Health Care Campus
Collaborators
Medispec
1. Study Identification
Unique Protocol Identification Number
NCT01272297
Brief Title
The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders
Acronym
LI-ESWT
Official Title
The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Medispec
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
Detailed Description
We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
LI-ESWT, Erectile Dysfunction, Non PDE5 inhibitor responders, Shock wave
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LI-ESWT
Arm Type
Experimental
Arm Description
Low intensity shock wave treatment- 12 sessions
Intervention Type
Device
Intervention Name(s)
LI-ESWT
Other Intervention Name(s)
Omnispec model ED1000
Intervention Description
Low intensity shock wave treatment - 12 sessions
Primary Outcome Measure Information:
Title
IIEF-ED Domain score
Description
Change of 5 points and above in IIEF-ED Domain score
Time Frame
17 weeks after first visit
Secondary Outcome Measure Information:
Title
rigidity scale
Description
a change to 3 or 4 points in the rigidty scale
Time Frame
17 weeks from visit 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ED of more than 6 months
Rigidity score ≤ 2 during PDE5i therapy
Stable heterosexual relationship for more than 3 months
Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .
Exclusion Criteria:
Prior surgery or radiotherapy in pelvic region
Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
Clinically significant chronic hematological disease
Anti-androgens, oral or injectable androgens
Cardiovascular conditions that prevent sexual activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, Prof
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Boaz Appel, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ezra Gerber, RN
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yaron Ofer, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Omar Massarwa, RN
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders
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