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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT01274949

Collaborator

Medispec (Industry)

Enrollment

Location

Arm

17.9

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Device: LI-ESWT	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LI-ESWT Low intensity shock wave treatment- 12 sessions	Device: LI-ESWT Low intensity shock wave treatment - 12 sessions Other Names: Omnispec model ED1000

Arm

Intervention/Treatment

Experimental: LI-ESWT

Low intensity shock wave treatment- 12 sessions

Device: LI-ESWT

Low intensity shock wave treatment - 12 sessions

Other Names:

Omnispec model ED1000

Outcome Measures

Primary Outcome Measures

IIEF-ED Domain score [17 weeks after first visit]
Change of 5 points and above in IIEF-ED Domain score

Secondary Outcome Measures

Rigidity scale [17 weeks after first visit]
a change to 3 or 4 points in the rigidty scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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