To evaluate the efficacy and safety of a new penile traction device (PTD) 'Penimaster PRO' in a group of patients with stable Peyronie's disease (PD) compared to a non-intervention group in a multicentre study trial.
93 patients with chronic stable PD (without ED, no significant pain, and with a unidirectional curvature of at least 45 degrees being stable for more than 3 months) were recruited and followed for a 12-week period. 47 patients were randomly assigned to 'PeniMaster PRO' group (PG) and 46 assigned to the non-intervention group (NIG). Patients were asked to apply the PTD 3-8 hours a day for 12 consecutive weeks with specific instructions regarding the progressive increase of traction force applied to the penis over time. The primary outcome of the study was to assess the change in the degree of curvature measured in the fully erect state after intracavernosal injection of Alprostadil at baseline, 1, 2 and 3 months. Other parameters such as the type of curvature, stretched penile length (SPL), Peyronie's Disease Questionnaire (PDQ), International Index of Erectile Function (IIEF-EF) and adverse events were also assessed in each visit.
41 patients in PG and 39 in NIG completed the study. There was an overall reduction in curvature of 31.2 degrees (p<0.001) at 12 weeks compared to baseline in the PG, representing a 41.1% improvement from the baseline which significantly correlated with the number of daily hours the device was applied in a dose-dependent manner. Those patients using the device less than 4 hours a day experienced a reduction of 15-25 degrees (mean 19.7 degrees, 28.8% improvement, p<0.05), while patients using the device more than 6 hours a day experienced greater curvature reduction ranging from 20 to 50 degrees (mean of 38.4 degrees, 51.4% improvement, p<0.0001). In contrast, no significant changes in curvature were observed in the NIG. Furthermore, SPL increased significantly in PG compared to baseline and compared to the NIG, ranging from 0.5 to 3.0 cm (mean 1.8 cm, p<0.05 IIEF-EF also improved in patients of the PG (mean of 5 points). Mild adverse events occurred in 43% of patients such as local discomfort and glans numbness.
The use of 'Penimaster PRO' PTD, a non-invasive treatment should be offered to patients with stable PD for three consecutive months before performing any corrective surgery, as this provided a significant reduction of the curvature, increase in penile length and a significant improvement of the symptoms and bother induced by PD. This article is protected by copyright. All rights reserved.
BJU international. 2018 Oct 26 [Epub ahead of print]
Ignacio Moncada, Pramod Krishnappa, Javier Romero, Josep Torremade, Agustin Fraile, Juan Ignacio Martinez-Salamanca, Hartmut Porst, Lawrence Levine
Hospital Universitario Sanitas la Zarzuela, Madrid, Spain., Hospital Universitario, 12 de Octubre, Madrid, Spain., Hospital Universitari de Bellvitge, Barcelona, Spain., Hospital Universitario Ramon y Cajal, Madrid, Spain., Hospital Universitario Puerta de Hierrro, Madrid, Spain., Private Institute for Urology and Sexual Medicine, Hamburg, Germany., Rush University Medical Center, Chicago, USA.