Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT)
LI-ESWT
1 other identifier
interventional
60
1 country
1
Brief Summary
Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).
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 Mar 2011
Typical duration 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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 8, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 24, 2012
May 1, 2012
2 years
March 8, 2011
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
3 months
Secondary Outcomes (1)
Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success
3 months
Study Arms (2)
Treatment LI-ESWT
ACTIVE COMPARATORDevice: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Sham control
PLACEBO COMPARATORWe use the same probe that induces the same sensation on the penis and the same noise yet no energy.
Interventions
Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Eligibility Criteria
You may qualify if:
- Prior prostatectomy surgery
- ED of more than 6 months
- Rigidity score \< 3 during PDE5i therapy
- Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
You may not qualify if:
- 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
Study Sites (1)
Rambam Medical Center
Haifa, 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
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 8, 2011
First Posted
March 17, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2013
Study Completion
December 1, 2013
Last Updated
May 24, 2012
Record last verified: 2012-05