Short summary

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 on peyronies disease.

This study is designed as 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 on peyronies disease.

We expect to include 50 male patients, with 25 in each arm (Intervention/placebo). We will collect data at baseline, and conduct follow-up after 1, 3 and 6 months.

Rationale

Purpose

• The purpose of this project is to assess the potential synergy of combining LI-ESWT and VED with manipulation exercises on patients diagnosed with PD. The data will be obtained from the patients using
• Peyronies 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

Background

Peyronies disease, named after the French physician Francois de la Peyronie, is an acquired multifactorial fibrotic disorder of the tunica albuginea of the penile corpus cavernosum. The condition is characterized by pain, plaque formation, penile curvature, plaque calcification and erectile dysfunction (ED). PD is often easily diagnosed by clinical examination and history without any lab-testing or imaging.

The prevalence of PD in the general population is uncertain and epidemiologic data are limited for which reason prevalence ranges from 0,3 up to 7,9% most commonly afflicting elderly men(1). To our knowledge the biggest prevalence study was conducted by Schwarzer et al. in 2001 showing a maximum prevalence (6,5%) among men older than 70. A review carried out by Ostrowski et al. suggests the PD prevalence rate found by Schwarzer et al.  is underestimated as patients fail to consult their general practitioner due to the embarrassment of their disease.

PD is often connected to ED (prevalence ranging from 40-60%)and it may have devastating consequences for the patients and influence their quality of live significantly.  

Pathophysiology

The exact underlying pathogenesis behind PD is not fully understood, and the etiology remains unclear. However, multiple theories have been proposed, but none fully manage to comprehend the disease spectrum, which is most likely multifactorial.

The tunica albuginea of the penis is the main site of calcification and plaque formation. A wide accepted thesis is that repeated microtraumas from intercourse, erections etc. in predisposed individuals may result in an inflammatory tissue response and collagen deposition. Along with the inflammatory tissue response comes chronic inflammation that leads to tissue affection, plaque formation, pain, curvature and ED. The microtrauma theory explained above attempts to justify PD is a wound healing disorder.

Numerous other theories and pathophysiological explanations have been suggested to influence the progress of the disease such as genetics, TGF-beta, tissue ischemia and autoimmunity. These theories will not be accounted for in the present protocol.

Description of the cohort

Men (18+) diagnosed with peyronies disease

Data and biological material

Questionnaires and penile curvature

Collaborating researchers and departments

Department of Urology, Odense University Hospital

• Professor Lars Lund, Dr. med.