Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases.
Level 2 - randomized trial
Open-label extension and follow-up phases of a randomized controlled trial
PubMed 33223425 · doi:10.1016/j.jsxm.2020.10.003
What was done
A randomized controlled trial enrolled 110 men with Peyronie's disease (PD) randomized 3:1 to RestoreX penile traction therapy (PTT) or no therapy for 3 months, followed by 3-month open-label (crossover for controls) and 3-month follow-up phases. Outcomes evaluated at 6 months (n = 64) and 9 months (n = 63) included adverse events, penile length, penile curvature, International Index of Erectile Function (IIEF) scores, Peyronie's Disease Questionnaire (PDQ) scores, and satisfaction.
What was found
Mean daily PTT use was 31.1 minutes. No significant adverse events occurred; temporary erythema and discomfort resolved within minutes. In intention-to-treat analysis, crossover control-to-PTT participants achieved 1.7–2.0 cm length gains and 18–20% curve improvements. Participants receiving 6 continuous months of PTT gained an additional 0.6–0.8 cm length without further curve change. In as-treated analysis (use ≥15 min/day), length gains reached 2.0–2.3 cm and curve improvement reached 18–21%. Overall, 95% of men treated for 6 months experienced length increases (mean 2.0–2.2 cm) and 61% experienced curvature reductions (16.8–21.4° [32.8–35.8%]). PDQ and all IIEF domains (except orgasmic function) improved significantly.
Why it matters
Shows that short-duration (~30 min/day) penile traction therapy confers sustained length and curvature improvements alongside subjective sexual function gains without severe side effects.
Limits
Substantial attrition occurred between initial enrollment (n = 110) and follow-up (n = 64 at 6 months, n = 63 at 9 months). The trial lacked an active comparator arm using traditional long-duration traction devices (3–9 hours/day) and had insufficient sample size for detailed subgroup comparisons during the extension phases.
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.