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

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: "MEDISPEC" treatment probe; Device: "MEDISPEC" Sham Probe; Device: Sham; Device: "MEDISPEC" Low intensity shock waves

• Registration Number: NCT01274156
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-12-14
• Status Verified: 2011-01
• Study First Submitted QC: 2011-01-10
• Last Update Submitted: 2011-01-10
• Study First Posted: 2011-01-11
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shock wave treatment	"MEDISPEC" treatment probe	-
"MEDISPEC" Sham	Sham	"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
shock wave treatment	"MEDISPEC" Low intensity shock waves	-
"MEDISPEC" Sham	"MEDISPEC" Sham Probe	"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe

Primary Outcome Measures

Name	Time	Method
International Index of Erectile function- Erectile Function Domain	At screening and 17 weeks later at last visit	An increase in score of 5points and above will be considered success.

Secondary Outcome Measures

Name	Time	Method
Rigidity scale	At screening and 17 weeks later at last visit	A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success
Flow Mediated Dilatation Technique	At screening and 17 weeks later at last visit	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.

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel