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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01317680
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Device: Omnispec model ED1000; Device: Sham control	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Mar 1, 2011
• Anticipated Primary Completion Date: Mar 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment LI-ESWT 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.	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.
Placebo Comparator: Sham control We use the same probe that induces the same sensation on the penis and the same noise yet no energy.	Device: Sham control; We use the same probe that induces the same sensation on the penis and the same noise yet no energy

Outcome Measures

Primary Outcome Measures

1. Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success [3 months]

Secondary Outcome Measures

1. Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Medical Center	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: i_gruenwald, MD, Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT01317680
• Other Study ID Numbers: 0037-11-RMB
• First Posted: Mar 17, 2011
• Last Update Posted: May 24, 2012
• Last Verified: May 1, 2012

• Keywords provided by i_gruenwald, MD, Rambam Health Care Campus: Erectile Dysfunction; ED; PDE5 inhibitors; LI-ESWT
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of May 24, 2012