PMID- 33223425
OWN - NLM
STAT- MEDLINE
DCOM- 20210212
LR  - 20210212
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 17
IP  - 12
DP  - 2020 Dec
TI  - Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: 
      Results From Open Label and Follow-up Phases.
PG  - 2462-2471
LID - S1743-6095(20)30939-5 [pii]
LID - 10.1016/j.jsxm.2020.10.003 [doi]
AB  - BACKGROUND: A randomized, controlled clinical trial evaluating the efficacy of 
      RestoreX traction therapy in men with Peyronie's disease (PD) has been completed, 
      with the 3-month results previously reported. The present study presents outcomes 
      from the open-label and follow-up phases of the original trial. AIM: To report 
      6-month (open-label phase) and 9-month (follow-up phase) outcomes from a 
      randomized, controlled trial (NCT03389854). METHODS: A randomized controlled 
      trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were 
      randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed 
      by 3-month open-label and follow-up phases. Key outcomes included adverse events 
      (AEs), changes in penile curvature and length, erectile function, and 
      standardized and nonstandardized assessments of PD. OUTCOMES: The primary 
      outcomes are safety, penile length, penile curvature, Peyronie's Disease 
      Questionnaire, International Index of Erectile Function, and satisfaction. 
      RESULTS: 6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a 
      mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with 
      temporary erythema and discomfort being most common and resolving within minutes. 
      On intent-to-treat analysis, control-to-PTT men experienced significant length 
      (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved 
      additional length (0.6-0.8 cm) without further curvature improvements. An 
      as-treated analysis of PTT use >/=15 minute/day demonstrated 2.0- to 2.3-cm length 
      gains (largest of any PTT to date) and 18-21% curve improvement. All sexual 
      function domains of the International Index of Erectile Function and Peyronie's 
      Disease Questionnaire were significantly improved (except orgasmic domain). 95% 
      of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% 
      had curve improvements (16.8-21.4 degrees  [32.8-35.8%]). RestoreX was preferred 3-4:1 
      over all other PD treatments, and 100% preferred it over other PTT devices. 
      CLINICAL IMPLICATIONS: Use of RestoreX 30 minutes daily results in significant 
      length and curve improvements in PD men without significant AEs. STRENGTHS & 
      LIMITATIONS: Strengths include largest randomized study of PTT, blinded 
      assessments, and inclusion of all-comers with few restrictions; limitations 
      include sample size that precludes comparisons between treatment cohorts and lack 
      of long-duration (>3-9 hours) treatment arm. CONCLUSION: PTT with RestoreX 
      results in significant improvements in length, curve, and subjective and 
      objective measures of sexual function without significant AEs. RestoreX PTT 
      represents a safe, conservative, low-cost option for managing men with PD. Joseph 
      J, Ziegelmann M, Alom M, et al. Outcomes of RestoreX Penile Traction Therapy in 
      Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex 
      Med 2020;17:2462-2471.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Joseph, Jason
AU  - Joseph J
AD  - Mayo Clinic, Rochester, MN, USA.
FAU - Ziegelmann, Matthew J
AU  - Ziegelmann MJ
AD  - Mayo Clinic, Rochester, MN, USA.
FAU - Alom, Manaf
AU  - Alom M
AD  - Mayo Clinic, Rochester, MN, USA.
FAU - Savage, Joshua
AU  - Savage J
AD  - Mayo Clinic, Rochester, MN, USA; Male Fertility and Peyronie's Clinic, Orem, UT, 
      USA.
FAU - Kohler, Tobias S
AU  - Kohler TS
AD  - Mayo Clinic, Rochester, MN, USA.
FAU - Trost, Landon
AU  - Trost L
AD  - Mayo Clinic, Rochester, MN, USA; Male Fertility and Peyronie's Clinic, Orem, UT, 
      USA. Electronic address: email@mfp.clinic.
LA  - eng
SI  - ClinicalTrials.gov/NCT03389854
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201120
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
SB  - IM
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - *Penile Induration/therapy
MH  - Penis
MH  - Traction
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Erectile Dysfunction
OT  - Hourglass
OT  - Peyronie's
OT  - Traction
EDAT- 2020/11/24 06:00
MHDA- 2021/02/13 06:00
CRDT- 2020/11/23 05:32
PHST- 2020/07/15 00:00 [received]
PHST- 2020/09/07 00:00 [revised]
PHST- 2020/10/03 00:00 [accepted]
PHST- 2020/11/24 06:00 [pubmed]
PHST- 2021/02/13 06:00 [medline]
PHST- 2020/11/23 05:32 [entrez]
AID - S1743-6095(20)30939-5 [pii]
AID - 10.1016/j.jsxm.2020.10.003 [doi]
PST - ppublish
SO  - J Sex Med. 2020 Dec;17(12):2462-2471. doi: 10.1016/j.jsxm.2020.10.003. Epub 2020 
      Nov 20.