Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment

NCT01601262 | Unknown Phase 3

• 1 other identifier: 0179-12-RMB
• Study Type: interventional
• Target: 300
• 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 the Efficacy and Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.

Conditions

Erectile Dysfunction

Keywords

ED; LI-ESWT

Outcome Measures

Primary Outcomes (1)

• IIEF-ED Domain score

  Severe ED (6≤IIEF-ED Domain score≤10): an increase of 7 points and above; Moderate ED (11≤IIEF-ED Domain score≤16): an increase of 5 points and above; Mild ED (17≤IIEF-ED Domain score≤25): an increase of 2 points and above.

  3 months

Secondary Outcomes (1)

• Rigidity Score Questionaire

  3 months

Study Arms (1)

Open label

EXPERIMENTAL

Device: Low Intensity Extracorporeal Shock waves (Cardiospec 1000)

Interventions

Low Intensity Extracorporeal Shock waves (Cardiospec 1000) DEVICE

We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.

Also known as: Cardiospec 1000

Open label

Eligibility Criteria

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

You may qualify if:

• Incomplete response to active treatment (not placebo) on first round but patient is still unsatisfied.
• Recurring ED (had improved on first round of shock wave therapy but after a certain period of time became clinically worse again) after shock wave therapy.
• A minimum of two sexual attempts per month.
• An IIEF-ED domain score ≤ 25 post screening, with or without PDE5i intake according to assessment on final visit of Shockwave previous treatment.
• A stable heterosexual relationship with the same partner for more than three months

You may not qualify if:

• Subjects that did not respond at all to the first round as well as those that did not respond sufficiently.
• Any pelvic surgery during the period after the first round.
• Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities arising during this period .
• cardiovascular conditions that prevent sexual activity.
• Recent Use of anti-androgens, or oral or injectable androgens
• Recent hormonal, neurologic, or psychological pathology

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

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. MD

  Rambam Health Care Campus

  STUDY DIRECTOR

Central Study Contacts

Yoram Vardi Vardi, Prof. MD

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

IL (1)