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

NCT01317693 | Unknown Phase 3 DMC

• 1 other identifier: 0571-10-RMB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success

  13 weeks

Secondary Outcomes (1)

• Rigidity Score Questionaire- an increase by at least 1 point is considered success

  13 weeks

Study Arms (1)

Treatment LI-ESWT

EXPERIMENTAL

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.

Device: Low intensity shock waves

Interventions

Low intensity shock waves DEVICE

1500 shocks, Energy Density - 0.09 mJ/mm2

Also known as: Omnispec model ED1000

Treatment LI-ESWT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Ilan Gruenwald, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Yoram Vardi, Prof.

  Rambam Health Care Campus

  STUDY DIRECTOR

Central Study Contacts

Ilan Gruenwald, MD

CONTACT

00972-4-8542882; i_gruenwald@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 17, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

IL (1)