Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.
Level 2 - randomized trial
Randomized single-blind controlled trial
PubMed 30916626 · doi:10.1097/JU.0000000000000245
What was done
A single-blind, intention-to-treat randomized controlled trial evaluated the RestoreX penile traction device in 110 men with Peyronie's disease and baseline curvature ≥30 degrees. Participants were randomized 3:1 to use the traction device for 30 to 90 minutes daily or to receive no therapy for 3 months. No exclusions were made for complex curvature, hourglass deformity, prior surgery/therapy, or calcification. Primary outcome was safety; secondary outcomes included penile length, curvature, and International Index of Erectile Function (IIEF-EF) scores.
What was found
Baseline characteristics included a mean age of 58.4 years, 49.7-month disease duration, and 59.3-degree curvature. At 3 months, the traction group demonstrated significant improvements over controls in penile length (+1.5 cm vs 0 cm, p < 0.001), penile curvature (-11.7° vs +1.3°, p < 0.01), and IIEF-EF score among men with erectile dysfunction (+4.3 vs -0.7, p = 0.01). Overall, 77% of men on traction experienced curvature improvement (mean -17.2°) and 94% achieved increased length (mean 1.6 cm). Adverse events were reported as transient and mild.
Why it matters
Standard penile traction protocols typically require 3 to 8 hours of daily use, which limits adherence. This trial demonstrates that a shorter daily protocol (30 to 90 minutes) can yield clinically meaningful reductions in curvature and gains in length over 3 months.
Limits
The control arm received no intervention rather than a sham device, precluding patient blinding. The 3:1 randomization ratio yielded a relatively small control cohort, and follow-up was limited to 3 months, leaving long-term durability of curvature correction unassessed.
Cited by
- supports Using a penile traction device for 30 minutes twice daily produces an increase in penile length of about 2 cm.
- supports Using a penile traction device for 30 minutes twice daily over 3 to 6 months increases length by approximately two centimeters.
- supports Penile traction devices can help straighten penile curvature caused by Peyronie's disease.