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The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i (LI-ESWT)

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
LI-ESWT
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, Radical Prostatectomy, Non PDE5 inhibitor responders, Shock wave

Eligibility Criteria

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

Inclusion Criteria:

  • Post Radical prostatectomy
  • 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

  • neuro-urology unit, Rambam Medical Center

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

First Posted
January 9, 2011
Last Updated
September 13, 2011
Sponsor
Rambam Health Care Campus
Collaborators
Medispec
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1. Study Identification

Unique Protocol Identification Number
NCT01274949
Brief Title
The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i
Acronym
LI-ESWT
Official Title
The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.
Detailed Description
We included severe ED patients that underwent radical prostatectomy at least one year previously and 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. This study further emphasises the need to study specific populations with unique etiologies causing ED.

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, Radical Prostatectomy, 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
20 (Anticipated)

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 after first visit

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: Post Radical prostatectomy 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
Ilan Gruenwald, MD
Organizational Affiliation
Rambam Medical Investigator
Official's Role
Study Director
Facility Information:
Facility Name
neuro-urology unit, Rambam Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i

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