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Clinical Trials/NCT01274156
NCT01274156
Completed
Phase 3

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

Rambam Health Care Campus1 site in 1 country60 target enrollmentAugust 2010
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ConditionsErectile Dysfunction

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Erectile Dysfunction
Sponsor
Rambam Health Care Campus
Enrollment
60
Locations
1
Primary Endpoint
International Index of Erectile function- Erectile Function Domain
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
November 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Rigidity scale(At screening and 17 weeks later at last visit)
  • Flow Mediated Dilatation Technique(At screening and 17 weeks later at last visit)

Study Sites (1)

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