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Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT) (LI-ESWT)

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Omnispec model ED1000
Sham control
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 Erectile Dysfunction, ED, PDE5 inhibitors, LI-ESWT

Eligibility Criteria

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

Inclusion Criteria:

  • Prior prostatectomy surgery
  • ED of more than 6 months
  • Rigidity score < 3 during PDE5i therapy
  • Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • 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

Active Comparator

Placebo Comparator

Arm Label

Treatment LI-ESWT

Sham control

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.

We use the same probe that induces the same sensation on the penis and the same noise yet no energy.

Outcomes

Primary Outcome Measures

Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success

Secondary Outcome Measures

Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success

Full Information

First Posted
March 8, 2011
Last Updated
May 23, 2012
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01317680
Brief Title
Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)
Acronym
LI-ESWT
Official Title
Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
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
No

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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, ED, PDE5 inhibitors, LI-ESWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment LI-ESWT
Arm Type
Active Comparator
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.
Arm Title
Sham control
Arm Type
Placebo Comparator
Arm Description
We use the same probe that induces the same sensation on the penis and the same noise yet no energy.
Intervention Type
Device
Intervention Name(s)
Omnispec model ED1000
Intervention 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)
Sham control
Intervention Description
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Primary Outcome Measure Information:
Title
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success
Time Frame
3 months

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: Prior prostatectomy surgery ED of more than 6 months Rigidity score < 3 during PDE5i therapy Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months Exclusion Criteria: 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 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_gruenwald@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

Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)

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