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Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group.
Primary Outcome
Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months.
A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization.
All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Active shockwaves |
|
| Placebo | Placebo Comparator | Placebo shockwaves |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-intensity extracorporeal shockwave therapy | Device | Active shockwaves |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in penile curvature | Change in penile curvature from baseline to follow-up at 1,3 and 6 months. Penile curvature is measured on pictures submitted by the patient. | penile curve will be assessed at baseline, and 1,3 and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score using the Visual Analogue Scale (VAS) | VAS is a subjective pain score ranging from 0-10 whereas 0 means no pain, and 10 being excruciating pain. Patients are asked to rank their average pain for the last 24 hours. | VAS will be assessed at baseline, and 1,3 and 6 months. |
| Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense university hospital | Recruiting | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D010411 | Penile Induration |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Placebo LI-ESWT |
| Device |
Placebo shockwaves |
|
| Penile pump | Device | both groups will be treated with a penile pump |
|
Erectile function is estimated using the IIEF-5 which is a 5 item questionnaire. Based on the patients answers a final score is merged. The definition of erectile dysfunction(ED) is; 5-7 (severe), 8-11(moderate), 12-16(mild-moderate), 17-21(mild) and 22-25 no ED. |
| IIEF-5 will be assessed at baseline, and 1,3 and 6 months. |
| Change in Peyronies disease questionnaire score | Questionnaire to evaluate the psychological/physical consequences of peyronies disease. | Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months. |
| D052801 |
| Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |