Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
NCT ID: NCT03143790
Last Updated: 2017-05-08
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
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SUSPENDED
NA
18 participants
INTERVENTIONAL
2014-08-31
2018-12-31
Brief Summary
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Detailed Description
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Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score).
Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2.
Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment.
For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ESWT
500 shockwave 3 different points on penis bilateral
Extracorporeal Shockwave Terapy
Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter
Placebo
500 shockwave 3 different points on penis bilateral
Extracorporeal Shockwave Terapy
Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter
Interventions
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Extracorporeal Shockwave Terapy
Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IIEF - less than 20
* EHS - less than 4
Exclusion Criteria
* not sexual active
* penile prostesis
18 Years
99 Years
MALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Martha Haahr M.D
M.D
Locations
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OUH
Odense, , Denmark
Countries
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Other Identifiers
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OUHL14.1
Identifier Type: -
Identifier Source: org_study_id
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