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

NCT ID: NCT01274923

Last Updated: 2011-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-10-31

Brief 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.

Detailed 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

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

shock wave treatment

Group Type: SHAM_COMPARATOR

"MEDISPEC" treatment probe

Intervention Type: DEVICE

shock wave treatment

"MEDISPEC" Sham

"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe

Group Type: SHAM_COMPARATOR

"MEDISPEC" treatment probe

Intervention Type: DEVICE

shock wave treatment

Interventions

"MEDISPEC" treatment probe

shock wave treatment

Intervention Type: DEVICE

Other Intervention Names

Omnispec model ED1000

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medispec

INDUSTRY

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Rambam Healthcare Campus

Locations

Rambam Health Care Campus

Haifa, Haifa District, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilan Gruenwald, MD

Role: CONTACT

i_gruenwald@rambam.health.gov.il

00972544474341

Yoram Gruenwald, Prof

Role: CONTACT

yvardi@rambam.health.gov.il

0097248542819

Facility Contacts

Ilan Gruenwald, MD

Role: primary

i_gruuenwald@rambam.health.gov.il

00972544474341

Other Identifiers

0200-09-rmb europe

Identifier Type: -

Identifier Source: org_study_id