Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 34060339 · doi:10.1097/JU.0000000000001792
What was done
Men after prostatectomy were randomized to either a control group or one of two penile traction therapy protocols (RestoreX device) for 6 months, followed by a 3-month open-label phase. The study reported findings from the 6-month randomized phase. The primary outcome was change in stretched penile length. Secondary outcomes included International Index of Erectile Function (IIEF) domain scores, erectogenic medication use, adverse events, and subjective satisfaction.
What was found
A total of 82 men (mean age 58.6 years) were randomized, with 6-month data completed for 55 men (25 controls and 30 traction therapy). At 6 months, penile traction achieved significantly better outcomes compared to control: greater preservation/gain of stretched penile length (+1.6 cm vs +0.3 cm, p <0.01), higher IIEF-Erectile Function scores (+0 vs -6.5, p=0.03), higher IIEF-Intercourse Satisfaction (+1 vs -3.5, p <0.01), and higher IIEF-Overall Sexual Satisfaction (0 vs -3, p <0.01). Use of intracavernosal injections was lower in the traction group (19% vs 50%, p <0.05), while phosphodiesterase-5 inhibitor use was similar (86% vs 94%, p=0.44). Adverse events were mild and transient, with 87% reporting willingness to repeat therapy.
Why it matters
Penile traction therapy provides a non-pharmacological, device-based approach to mitigate penile shortening and sexual dysfunction commonly experienced following radical prostatectomy.
Limits
The trial was conducted at a single center with a modest sample size and substantial attrition (33% lost to follow-up by 6 months). Blinding was not feasible given the physical device intervention, and multicenter external validation is required.
Cited by
- context 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.