Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.

Study Overview
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Brief Summary
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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 Peyronie's Disease Questionnaire (PDQ) Visual Analogue Scale score (VAS) International Index of Erectile Function 5 (IEFF-5) Penile curve measurements (gold standard) on pictures before and after treatment Plaque size 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.

Official Title
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A Prospective Randomized Double Blinded Placebo Controlled Clinical Trial Evaluating the Combined Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) and Vacuum Erectile Device Combined With Manipulation Exercises on Peyronies Disease.

Conditions
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Peyronie Disease

Intervention / Treatment
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* Device: low-intensity extracorporeal shockwave therapy
* Device: Placebo LI-ESWT
* Device: Penile pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PD for more than 6 months Penile curve greater than 30 degrees and less than 90 degrees Age 18-80 No previous penile surgery Informed consent Able to speak and understand Danish Exclusion Criteria: Penile curve greater than 90 degrees Previous surgery for PD Patients undergoing other interventions for PD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Active shockwaves | Device: low-intensity extracorporeal shockwave therapy<br>* Active shockwaves<br>Device: Penile pump<br>* both groups will be treated with a penile pump<br>|
| Placebo Comparator: Placebo<br>Placebo shockwaves | Device: Placebo LI-ESWT<br>* Placebo shockwaves<br>Device: Penile pump<br>* both groups will be treated with a penile pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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. |