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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active LI-ESWT | Experimental | 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. |
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| Sham | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) | Device | Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF-5 Score 1 | Change in International Index of Erectile Function (IIEF-5) score compared to baseline | One month after final treatment session |
| IIEF-5 Score 3 | Change in International Index of Erectile Function (IIEF-5) score compared to baseline | Three months after final treatment session |
| IIEF-5 Score 6 | Change in International Index of Erectile Function (IIEF-5) score compared to baseline | Six months after final treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| EDITS | Erectile Dysfunction Inventory of Treatment Satisfaction score | One month after final treatment session |
| RigiScan | Change in nocturnal erections compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Moumneh, BSC.med | Contact | +45234826423 | almou15@student.sdu.dk | |
| Lars Lund, Professor | Contact | lars.lund@rsyd.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40287933 | Derived | Pedersen TB, Secher C, Moumneh A, Hvid N, Lund M, Fojecki G, Lund L. A Prospective Randomized Study on Low-Energy Extracorporeal Shock Wave Therapy for Erectile Dysfunction After Radical Prostatectomy. J Urol. 2025 Aug;214(2):156-166. doi: 10.1097/JU.0000000000004576. Epub 2025 Apr 27. |
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Randomised, single-blinded, placebo-controlled trial
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Sham LI-ESWT treatment.
| One month after final treatment session |
| EHS 1 | Change in Erection Hardness Score compared to baseline | One month after final treatment session |
| EHS 3 | Change in Erection Hardness Score compared to baseline | Three months after final treatment session |
| EHS 6 | Change in Erection Hardness Score compared to baseline | Six months after final treatment session |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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