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

Phase 3

• Conditions: Erectile Dysfunction
• Interventions: Device: Omnispec model ED1000; Device: Sham control

• Registration Number: NCT01317680
• Lead Sponsor: Rambam Health Care Campus

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-24
• Primary Completion: 2013-03
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment LI-ESWT	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	Sham control	We use the same probe that induces the same sensation on the penis and the same noise yet no energy.

Primary Outcome Measures

Name	Time	Method
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success	3 months

Secondary Outcome Measures

Name	Time	Method
Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success	3 months

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel