Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction
NCT ID: NCT01274156
Last Updated: 2011-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2010-08-31
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders
NCT01274923
Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
NCT00901056
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
NCT01262157
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
NCT01317693
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease
NCT04821115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
shock wave treatment
"MEDISPEC" treatment probe
300 shocks in 5 different anatomical locations of the penis.
"MEDISPEC" Low intensity shock waves
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
"MEDISPEC" Sham
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
"MEDISPEC" Sham Probe
Sham probe applied same as treatment probe without energy
Sham
Probe does not deliver energy but creates same noise and sensation of active probe
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
"MEDISPEC" treatment probe
300 shocks in 5 different anatomical locations of the penis.
"MEDISPEC" Sham Probe
Sham probe applied same as treatment probe without energy
"MEDISPEC" Low intensity shock waves
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
Sham
Probe does not deliver energy but creates same noise and sensation of active probe
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medispec
INDUSTRY
Rambam Health Care Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rambam Healthcare Campus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rambam Health Care Campus
Haifa, Israel, Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3060 RMB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.