NCT03530540

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peyronie Disease

Interventions

Type	Name	Description
DEVICE	low-intensity extracorporeal shockwave therapy	Active shockwaves
DEVICE	Placebo LI-ESWT	Placebo shockwaves
DEVICE	Penile pump	both groups will be treated with a penile pump

Timeline

• Start date: 2018-03-13
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2018-05-21
• Last updated: 2019-03-14

Locations

1 site across 1 country: Denmark