Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms

NCT01442077 | Unknown Phase 3

• 1 other identifier: 0359-11-RMB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success

  3 months

Secondary Outcomes (1)

• Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success

  3 months

Study Arms (4)

arm 1

ACTIVE COMPARATOR

Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments.

Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

arm 2

ACTIVE COMPARATOR

Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.

Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

arm 3

ACTIVE COMPARATOR

Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).

Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

arm 4

ACTIVE COMPARATOR

Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).

Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

Interventions

Extracorporeal Shockwave Therapy Generator (Omnispec ED1000) DEVICE

Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).

Also known as: No other names

arm 1; arm 2; arm 3; arm 4

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ED for more than six months in duration.
• At least 50% unsuccessful sexual intercourses for 4 attempts at 4 different days.
• Previous positive experience with PDE5iswithin the past six months.
• A minimum of two sexual attempts per month.
• An IIEF-ED domain score of ≥19, post screening PDE5i intake.
• An IIEF-ED domain score of ≥17 and a Rigidity score ≥ 3 , post screening with PDE5i intake
• A Rigidity score ≥ 3 post screening PDE5i intake.
• A stable heterosexual relationship with the same partner for more than three months.
• Delta IIEF-ED domain score ≤5 points on visit 1 (after 1 month wash out) compared to the IIEF-ED domain score on screening.

You may not qualify if:

• Prior prostate surgery.
• Any cause of ED other than of vascular etiology.
• Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities including Peyrone's disease.
• Clinically significant chronic hematological disease.
• Cardiovascular conditions that prevent sexual activity.
• History of heart attack, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study.
• Cancer within the past five years.
• Use of anti-androgens, or oral or injectable androgens
• Use of any other treatments for ED that includes oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories within seven days of screening.
• Hormonal, neurologic, or psychological pathology.

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

• Yoram Vardi, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoram Vardi, Prof.

CONTACT

00972-4-8542819; yvardi@rambam.health.gov.il

Ilan Gruenwald, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

IL (1)