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

The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274156

Acronym

LI-ESWT

Enrollment

Registered

2011-01-11

Start date

2010-08-31

Completion date

2010-11-30

Last updated

2011-01-11

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, Low Intensity Shock Wave

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.

Interventions

DEVICEMEDISPEC treatment probe

300 shocks in 5 different anatomical locations of the penis.

DEVICEMEDISPEC Sham Probe

Sham probe applied same as treatment probe without energy

DEVICEMEDISPEC Low intensity shock waves

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

DEVICESham

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Israel

Outcome results

None listed

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