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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01317693

Enrollment

Registered

2011-03-17

Start date

2011-03-31

Completion date

2013-12-31

Last updated

2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

LI-ESWT, Erectile Dysfunction, ED, Shock waves, Therapy

Brief summary

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.

Interventions

DEVICELow intensity shock waves

1500 shocks, Energy Density - 0.09 mJ/mm2

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success	13 weeks

Secondary

Measure	Time frame
Rigidity Score Questionaire- an increase by at least 1 point is considered success	13 weeks

Countries

Israel

Contacts

Primary ContactIlan Gruenwald, MD

i_gruenwald@rambam.health.gov.il00972-4-8542882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026