Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders

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: Recruiting

Administrative data

• NCT number: NCT01274923
• Other study ID #: 0200-09-rmb europe
• Status: Recruiting
• Phase: Phase 3
• First received: January 9, 2011
• Last updated: May 17, 2011
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: January 2011
• Source: Rambam Health Care Campus
• Contact: Ilan Gruenwald, MD
• Phone: 00972544474341
• Email: i_gruenwald[@]rambam.health.gov.il
• 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. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• 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
shock wave treatment

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