Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— LI-ESWT  

Official title:

The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274156
• Other study ID #: 3060 RMB
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2010
• Last updated: January 10, 2011
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Description:

This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• ED of more than 6 months

• Rigidity score = 3 under PDE5i therapy

• SHIM =21 under PDE5i therapy

• Non- hormonal, neurological or psychological pathology

• Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

• Prior prostatectomy surgery

• 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:
• "MEDISPEC" treatment probe
300 shocks in 5 different anatomical locations of the penis.
• "MEDISPEC" Sham Probe
Sham probe applied same as treatment probe without energy
• "MEDISPEC" Low intensity shock waves
Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min
• Sham
Probe does not deliver energy but creates same noise and sensation of active probe

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Medispec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile function- Erectile Function Domain	An increase in score of 5points and above will be considered success.	At screening and 17 weeks later at last visit	No
Secondary	Rigidity scale	A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success	At screening and 17 weeks later at last visit	No
Secondary	Flow Mediated Dilatation Technique	A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.	At screening and 17 weeks later at last visit	No