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Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

NCT ID: NCT01317693

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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LI-ESWT Erectile Dysfunction ED Shock waves Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment LI-ESWT

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.

Group Type EXPERIMENTAL

Low intensity shock waves

Intervention Type DEVICE

1500 shocks, Energy Density - 0.09 mJ/mm2

Interventions

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Low intensity shock waves

1500 shocks, Energy Density - 0.09 mJ/mm2

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
* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
* Positive response to PDE-5 inhibitors
* IIEF-5 domain score of 12-20 denoting mild to severe ED
* Non-Neurological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria

* NPT - normal/flat
* Prior prostatectomy surgery
* Any cause of ED other than vascular related
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Cardiovascular conditions that prevent sexual activity
* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
* Cancer within the past 5 years.
* Anti-androgens, oral or injectable androgens
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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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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Ilan Gruenwald, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Yoram Vardi, Prof.

Role: STUDY_DIRECTOR

Rambam Health Care Campus

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ilan Gruenwald, MD

Role: CONTACT

Phone: 00972-4-8542882

Email: [email protected]

Facility Contacts

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Ilan Gruenwald, MD

Role: primary

Other Identifiers

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0571-10-RMB

Identifier Type: -

Identifier Source: org_study_id