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

This study is currently recruiting participants.
Verified May 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
i_gruenwald, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01317680
First received: March 8, 2011
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Erectile Dysfunction
Device: Omnispec model ED1000
Device: Sham control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317680

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD    00972-4-8542882    i_gruenwald@rambam.health.gov.il   
Principal Investigator: Yoram Vardi, Prof         
Principal Investigator: Ilan Gruenwald, MD         
Sub-Investigator: Boaz Appel, MD         
Sub-Investigator: Yaron Ofer, MD         
Sub-Investigator: Suliman Nassar, MD         
Sub-Investigator: Omar Massarwa, RN BA         
Sub-Investigator: Ezra Gerber, RN BA         
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: i_gruenwald, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01317680     History of Changes
Other Study ID Numbers: 0037-11-RMB
Study First Received: March 8, 2011
Last Updated: May 23, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Erectile Dysfunction
ED
PDE5 inhibitors
LI-ESWT

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014