Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
NCT ID: NCT04059341
Last Updated: 2019-08-16
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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UNKNOWN
NA
70 participants
INTERVENTIONAL
2019-09-01
2020-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Active LI-ESWT
Active group receives five sessions of low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG.
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
Sham
Sham group receives five sessions of sham low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG with a shockwave absorbing adapter.
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
Interventions
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Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
Eligibility Criteria
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Inclusion Criteria
* Non nerve-sparing or nerve-sparing RP.
* Age 20-80 years
* Have been in a relationship for more than 3 months.
* Sexually active
* Patient can give informed consent.
Exclusion Criteria
* Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
* Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
20 Years
80 Years
MALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Lars Lund,MD
Professor
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ELIESWTEDRP
Identifier Type: -
Identifier Source: org_study_id
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