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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

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

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

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

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: