Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)

Rambam Health Care Campus1 site in 1 country60 target enrollmentMarch 2011

ConditionsErectile Dysfunction

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Rambam Health Care Campus
Enrollment: 60
Locations: 1
Primary Endpoint: Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

December 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Rambam Health Care Campus

Responsible Party

Principal Investigator

i_gruenwald

Rambam Health Care Campus

Eligibility Criteria

Inclusion Criteria

•Prior prostatectomy surgery
•ED of more than 6 months
•Rigidity score \< 3 during PDE5i therapy
•Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria

•Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
•Clinically significant chronic hematological disease
•Anti-androgens, oral or injectable androgens
•Radiotherapy in pelvic region