PMID- 30365247
OWN - NLM
STAT- MEDLINE
DCOM- 20191217
LR  - 20191217
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 123
IP  - 4
DP  - 2019 Apr
TI  - Penile traction therapy with the new device 'Penimaster PRO' is effective and 
      safe in the stable phase of Peyronie's disease: a controlled multicentre study.
PG  - 694-702
LID - 10.1111/bju.14602 [doi]
AB  - OBJECTIVES: 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 with a non-intervention group in a multicentre study. MATERIAL AND 
      METHODS: A total of 93 patients with chronic stable PD (without erectile 
      dysfunction, with no significant pain, and with a unidirectional curvature of at 
      least 45 degrees  being stable for > 3 months) were recruited and followed for a 12-week 
      period. Of these patients, 47 were randomly assigned to the Penimaster PRO group 
      (PG) and 46 to the non-intervention group (NIG). Patients were asked to apply the 
      PTD 3-8 h 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 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 variables, such as the type of curvature, 
      stretched penile length (SPL), Peyronie's Disease Questionnaire (PDQ) scores, 
      erectile function domain of the International Index of Erectile function 
      (IIEF-EF) score and adverse events (AEs) were also assessed in each visit. 
      RESULTS: Forty-one patients in the PG and 39 in the 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 baseline, 
      which significantly correlated with the number of daily hours the device was 
      applied in a dose-dependent manner. Those patients using the device < 4 h/day 
      experienced a reduction of 15 degrees -25 degrees  (mean 19.7 degrees , 28.8% improvement; P < 0.05), 
      while patients using the device > 6 h/day experienced greater curvature 
      reduction, ranging from 20 degrees  to 50 degrees  (mean of 38.4 degrees , 51.4% improvement; P < 0.001). 
      In contrast, no significant changes in curvature were observed in the NIG. 
      Furthermore, SPL increased significantly in the PG compared to baseline and 
      compared with the NIG, ranging from 0.5 to 3.0 cm (mean 1.8 cm; P < 0.05). The 
      IIEF-EF score also improved in patients in the PG (by a mean of 5 points). Mild 
      AEs occurred in 43% of patients, such as local discomfort and glans numbness. 
      CONCLUSION: The use of the Penimaster PRO PTD, a non-invasive treatment, should 
      be offered to patients with stable PD for 3 consecutive months before performing 
      any corrective surgery, as this provided a significant reduction in the 
      curvature, an increase in penile length and a significant improvement of the 
      symptoms and bother induced by PD.
CI  - (c) 2018 The Authors BJU International (c) 2018 BJU International Published by John 
      Wiley & Sons Ltd.
FAU - Moncada, Ignacio
AU  - Moncada I
AUID- ORCID: 0000-0001-9194-0660
AD  - Hospital Universitario Sanitas la Zarzuela, Madrid, Spain.
FAU - Krishnappa, Pramod
AU  - Krishnappa P
AD  - Hospital Universitario Sanitas la Zarzuela, Madrid, Spain.
AD  - NU Hospitals, Bangalore, Karnataka, India.
FAU - Romero, Javier
AU  - Romero J
AD  - Hospital Universitario 12 de Octubre, Madrid, Spain.
FAU - Torremade, Josep
AU  - Torremade J
AD  - Hospital Universitari de Bellvitge, Barcelona, Spain.
FAU - Fraile, Agustin
AU  - Fraile A
AD  - Hospital Universitario Ramon y Cajal, Madrid, Spain.
FAU - Martinez-Salamanca, Juan Ignacio
AU  - Martinez-Salamanca JI
AD  - Hospital Universitario Puerta de Hierro, Madrid, Spain.
FAU - Porst, Hartmut
AU  - Porst H
AD  - Private Institute for Urology and Sexual Medicine, Hamburg, Germany.
FAU - Levine, Laurence
AU  - Levine L
AD  - Rush University Medical Center, Chicago, IL, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20181122
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
SB  - IM
CIN - Nat Rev Urol. 2019 Feb;16(2):66-67. PMID: 30429529
CIN - Aktuelle Urol. 2019 Dec;50(6):574. PMID: 31770800
MH  - Aged
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Compliance/*statistics & numerical data
MH  - Patient Education as Topic
MH  - Patient Satisfaction
MH  - Penile Erection/*physiology
MH  - Penile Induration/*physiopathology/therapy
MH  - Penis/drug effects/*physiopathology
MH  - Traction/*methods
MH  - Treatment Outcome
OTO - NOTNLM
OT  - #Andrology
OT  - #Peyronies
OT  - Conservative treatment
OT  - Penile Curvature
OT  - Penimaster PRO
OT  - Peyronie's disease
OT  - penile traction therapy
EDAT- 2018/10/27 06:00
MHDA- 2019/12/18 06:00
CRDT- 2018/10/27 06:00
PHST- 2018/10/27 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2018/10/27 06:00 [entrez]
AID - 10.1111/bju.14602 [doi]
PST - ppublish
SO  - BJU Int. 2019 Apr;123(4):694-702. doi: 10.1111/bju.14602. Epub 2018 Nov 22.