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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01442077 |
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Date of registration:
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26/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms
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Scientific title:
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Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01442077 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Israel
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Contacts
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Name:
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Yoram Vardi, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rambam Health Care Campus |
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Name:
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Yoram Vardi, Prof. |
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Address:
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Telephone:
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00972-4-8542819 |
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Email:
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yvardi@rambam.health.gov.il |
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Affiliation:
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Name:
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Yoram Vardi, Prof. |
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Address:
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Telephone:
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00972-4-8542819 |
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Email:
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yvardi@rambam.health.gov.il |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ED for more than six months in duration.
- At least 50% unsuccessful sexual intercourses for 4 attempts at 4 different
days.
- Previous positive experience with PDE5iswithin the past six months.
- A minimum of two sexual attempts per month.
- An IIEF-ED domain score of =19, post screening PDE5i intake.
- An IIEF-ED domain score of =17 and a Rigidity score = 3 , post screening with PDE5i
intake
- A Rigidity score = 3 post screening PDE5i intake.
- A stable heterosexual relationship with the same partner for more than three months.
- Delta IIEF-ED domain score =5 points on visit 1 (after 1 month wash out) compared to
the IIEF-ED domain score on screening.
Exclusion Criteria:
- Prior prostate surgery.
- Any cause of ED other than of vascular etiology.
- Any unstable medical or psychiatric condition, spinal cord injury, or penile
anatomical abnormalities including Peyrone's disease.
- Clinically significant chronic hematological disease.
- Cardiovascular conditions that prevent sexual activity.
- History of heart attack, stroke, or life-threatening arrhythmia within 6 months prior
to enrollment into the study.
- Cancer within the past five years.
- Use of anti-androgens, or oral or injectable androgens
- Use of any other treatments for ED that includes oral medications, vacuum devices,
constrictive devices, injections, or urethral suppositories within seven days of
screening.
- Hormonal, neurologic, or psychological pathology.
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Erectile Dysfunction
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Intervention(s)
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Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
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Primary Outcome(s)
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Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
[Time Frame: 3 months]
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Secondary Outcome(s)
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Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success
[Time Frame: 3 months]
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Secondary ID(s)
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0359-11-RMB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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