Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction
LI-ESWT
The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedJanuary 11, 2011
January 1, 2011
3 months
December 14, 2010
January 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Index of Erectile function- Erectile Function Domain
An increase in score of 5points and above will be considered success.
At screening and 17 weeks later at last visit
Secondary Outcomes (2)
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 Arms (2)
shock wave treatment
ACTIVE COMPARATOR"MEDISPEC" Sham
SHAM COMPARATOR"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Interventions
300 shocks in 5 different anatomical locations of the penis.
Sham probe applied same as treatment probe without energy
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
Probe does not deliver energy but creates same noise and sensation of active probe
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rambam Health Care Campuslead
- Medispeccollaborator
Study Sites (1)
Rambam Health Care Campus
Haifa, Israel, 31096, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 14, 2010
First Posted
January 11, 2011
Study Start
August 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 11, 2011
Record last verified: 2011-01