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The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders

NCT ID: NCT01272297

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction

Keywords

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LI-ESWT Erectile Dysfunction Non PDE5 inhibitor responders Shock wave

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LI-ESWT

Low intensity shock wave treatment- 12 sessions

Group Type EXPERIMENTAL

LI-ESWT

Intervention Type DEVICE

Low intensity shock wave treatment - 12 sessions

Interventions

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LI-ESWT

Low intensity shock wave treatment - 12 sessions

Intervention Type DEVICE

Other Intervention Names

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Omnispec model ED1000

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medispec

INDUSTRY

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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i_gruenwald

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoram Vardi, Prof

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Ilan Gruenwald, MD

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Boaz Appel, MD

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Ezra Gerber, RN

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Yaron Ofer, MD

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Omar Massarwa, RN

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Other Identifiers

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shock wave III

Identifier Type: -

Identifier Source: org_study_id