Novel penile traction device safely improves curvature, length in men with Peyronie’s disease
It is safe to use the RestoreX device for penile traction therapy for 30–90 minutes per day, with no serious adverse events reported, according to a study. The novel device significantly and clinically improves penile curvature and length, as well as erectile function, in men with Peyronie’s disease.
“Current penile traction therapy devices have significant limitations, including the need to use them for 3–8 hours per day,” the researchers said. “Given these issues, the novel RestoreX penile traction therapy device was developed in cooperation with Mayo Clinic.”
This randomized, controlled, single-blind, intent-to-treat trial enrolled and assigned men with Peyronie’s disease either to the penile traction therapy device for 30–90 minutes per day or to no therapy for 3 months. Criteria for inclusion included curvature ≥30 degrees. There were no study exclusions due to complex curvature, hourglass deformity, prior Peyronie’s disease therapy or surgery, or calcification.
Safety was the primary outcome. Penile length and curvature and questionnaire responses were the secondary outcomes.
Overall, 110 men (mean age, 58.4 years) were randomly assigned 3:1 to the penile traction therapy group or the control group. Patients had a 49.7-month history of Peyronie’s disease and a penile curvature of 59.3 degrees.
The RestoreX device was well tolerated among patients, resulting in only transient and mild adverse events. Men who received penile traction therapy showed significant improvements at 3 months in penile length (1.5 vs 0 cm; p<0.001), curvature (–11.7 vs 1.3 degrees; p<0.01) and erectile function (4.3 vs –0.7; p=0.01), according to the International Index of Erectile Function-Erectile Function, compared with controls. [J Urol 2019;202:599-610]
Of the men assigned to penile traction therapy, 77 percent had improved curvature (mean, –17.2 degrees in 28.2 percent of responders), and 94 percent achieved an increase in length (1.6 cm in 10.9 percent of responders). Counter bending and the white line indicator improved efficacy, supporting key device innovations.
All of the men who had previously used other penile traction therapy devices preferred the RestoreX device, according to the researchers.
“To our knowledge these data represent the only reported improvements for any device used less than 3–8 hours per day,” the researchers said.
Another recent study found that the RestoreX device in combination with collagenase Clostridium histolyticum (CCH) significantly improved curvature and penile length in men with Peyronie’s disease over CCH along or CCH plus other penile traction therapy devices. [J Sex Med 2019;16:891-900]
Furthermore, the RestoreX device led to a mean 71-percent curvature and to increased penile length in men receiving CCH therapy.
Another penile traction device, the Penimaster PRO, also provided a significant reduction in curvature, an increase in length, and a significant improvement of the symptoms and bother caused by Peyronie’s disease. [BJU Int 2019;123:694-702]