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Completed

NCT Number: NCT01274156

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

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Rambam Health Care Campus

Haifa, Israel, 31096

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"MEDISPEC" treatment probe

Device

300 shocks in 5 different anatomical locations of the penis.

Other names: VASCUSPEC

"MEDISPEC" Sham Probe

Device

Sham probe applied same as treatment probe without energy

Other names: VASCUSPEC

"MEDISPEC" Low intensity shock waves

Device

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

Other names: VASCULOSPEC

SHAM

Device

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

Other names: Vasculospec

Primary outcomes

  1. International Index of Erectile function- Erectile Function Domain

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

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

Secondary outcomes

  1. Rigidity scale

    Time frame: 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

  2. Flow Mediated Dilatation Technique

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Medispec

Registry information

Official study title

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

Acronym: LI-ESWT

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 11, 2011
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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