Erectile Dysfunction, Extracorporeal Shockwave Therapy, Radical Prostatectomy
Conditions
Keywords
Radical Prostatectomy, Prostatectomy, Nerve-sparing, Non nerve-sparing, Erectile dysfunction, Erectile function, Shockwave, LI-ESWT, ESWT, Low intensity extracorporeal shockwave therapy, extracorporeal shockwave therapy
Brief summary
The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).
Interventions
DEVICELow Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Sham LI-ESWT treatment.
Intervention model description
Randomised, single-blinded, placebo-controlled trial
Eligibility
Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Radically prostatectomised men * 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
* Men with ED of neuropathological or psychogenic origin * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IIEF-5 Score 1 | One month after final treatment session | Change in International Index of Erectile Function (IIEF-5) score compared to baseline |
| IIEF-5 Score 3 | Three months after final treatment session | Change in International Index of Erectile Function (IIEF-5) score compared to baseline |
| IIEF-5 Score 6 | Six months after final treatment session | Change in International Index of Erectile Function (IIEF-5) score compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EHS 3 | Three months after final treatment session | Change in Erection Hardness Score compared to baseline |
| EDITS | One month after final treatment session | Erectile Dysfunction Inventory of Treatment Satisfaction score |
| EHS 6 | Six months after final treatment session | Change in Erection Hardness Score compared to baseline |
| RigiScan | One month after final treatment session | Change in nocturnal erections compared to baseline |
| EHS 1 | One month after final treatment session | Change in Erection Hardness Score compared to baseline |
Countries
Denmark
Contacts
Primary ContactAli Moumneh, BSC.med
Backup ContactLars Lund, Professor
Outcome results
None listed