Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study

A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01262157

Acronym

LI-ESWT

Enrollment

Registered

2010-12-17

Start date

2010-04-30

Completion date

2012-01-31

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction, PDE5 Inhibitor, Low intensity shock wave therapy.

Brief summary

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Detailed description

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Interventions

DEVICEExtracorporeal Shockwave Therapy Generator (Vascuspec)

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

DEVICELow intensity shock wave therapy

Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 85 Years

Healthy volunteers

Inclusion criteria

* ED of more than 6 months * Rigidity score \< 3 during PDE5i therapy * SHIM \<21 during 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

Design outcomes

Primary

Measure	Time frame	Description
IIEF-ED Domain	17 weeks	A change of 5 points or more will indicate success

Secondary

Measure	Time frame	Description
rigidity score	17 weeks	a scale of 3 and above indicates success

Countries

Israel

Contacts

Primary ContactYoram Vardi, Prof

yvardi@rambam.health.gov.il++97248542819

Backup ContactIlan Gruenwald, MD

i_gruenwald@rambam.health.gov.il++97248542819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026