Peyronie Disease Clinical Trial
Official title:
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.
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.
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