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

Rambam Health Care Campus60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Erectile Dysfunction

Interventions

"MEDISPEC" treatment probeDEVICE

300 shocks in 5 different anatomical locations of the penis.

"MEDISPEC" Sham ProbeDEVICE

Sham probe applied same as treatment probe without energy

"MEDISPEC" Low intensity shock wavesDEVICE

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Rambam Health Care Campus

Haifa, Israel, Israel

Outcomes

Primary Outcomes

International Index of Erectile function- Erectile Function Domain

An increase in score of 5points and above will be considered success.

Time frame: At screening and 17 weeks later at last visit

Secondary Outcomes

Rigidity scale

A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success

Time frame: At screening and 17 weeks later at last visit

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.

Time frame: At screening and 17 weeks later at last visit

Data from ClinicalTrials.gov

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