Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)

Erectile Dysfunction Clinical Trial

— LI-ESWT  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01317680
• Other study ID #: 0037-11-RMB
• Status: Recruiting
• Phase: Phase 3
• First received: March 8, 2011
• Last updated: May 23, 2012
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2012
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Omnispec model ED1000
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.
• Sham control
We use the same probe that induces the same sensation on the penis and the same noise yet no energy

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success		3 months	No
Secondary	Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success		3 months	No