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Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Low intensity shock waves
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring LI-ESWT, Erectile Dysfunction, ED, Shock waves, Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment LI-ESWT

Arm Description

Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) 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.

Outcomes

Primary Outcome Measures

Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success

Secondary Outcome Measures

Rigidity Score Questionaire- an increase by at least 1 point is considered success

Full Information

First Posted
March 8, 2011
Last Updated
December 18, 2012
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01317693
Brief Title
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Official Title
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.

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, ED, Shock waves, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment LI-ESWT
Arm Type
Experimental
Arm Description
Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) 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 waves
Other Intervention Name(s)
Omnispec model ED1000
Intervention Description
1500 shocks, Energy Density - 0.09 mJ/mm2
Primary Outcome Measure Information:
Title
Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Rigidity Score Questionaire- an increase by at least 1 point is considered success
Time Frame
13 weeks

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Gruenwald, MD
Phone
00972-4-8542882
Email
i_gruenwald@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, Prof.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
Phone
00972-4-8542882
Email
i_gruewald@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Yoram Vardi, Prof.
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
First Name & Middle Initial & Last Name & Degree
Boaz Appel, MD
First Name & Middle Initial & Last Name & Degree
Yaron Ofer, MD
First Name & Middle Initial & Last Name & Degree
Suliman Nassar, MD
First Name & Middle Initial & Last Name & Degree
Omar Massarwa, RN BA
First Name & Middle Initial & Last Name & Degree
Ezra Gerber, RN BA

12. IPD Sharing Statement

Learn more about this trial

Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

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