SCOTTSDALE, Ariz. -- A penile traction therapy (PTT) device produced lasting improvements in men after prostatectomy, a researcher reported.
The current data builds on an of 6-month data from 55 men (average age 58.6) who were randomly assigned to control (n=25) or treatment with PTT (n=30) after prostatectomy. The interventions began 1 month post-surgery, and those in the PTT group used the device for 30 or 90 minutes a day.
At 6 months, PTT led to greater improvements/preservation of penile length (+1.6 vs +0.3 cm for controls, P<0.01), erectile function (IIEF-Erectile Function +0 vs -6.5, P=0.03), intercourse satisfaction (IIEF-Intercourse Satisfaction +1 vs -3.5, P<0.01), and overall sexual satisfaction (IIEF-Overall Sexual Satisfaction 0 vs -3, P<0.01), according to Landon Trost, MD, of the Male Fertility and Peyronie's Clinic in Orem, Utah, who presented updated results at the Sexual Medicine Society of North America (SMSNA) annual meeting.
"More penile traction therapy men reported satisfaction or improvement in penile length than controls [no treatment]. Adverse events were transient and mild; 87% would choose to repeat therapy, and 93% would recommend it to others," Trost and colleagues wrote in the Journal of Urology.
"If confirmed by other investigators, this would represent the most notable improvement in erectile function post-prostatectomy since the introduction of nerve-sparing techniques," said Trost, who invented the RestoreX device while at the Mayo Clinic in Rochester, Minnesota, where the study was conducted. RestoreX is , and demonstrated benefits in men with Peyronie's disease in a study by Trost and colleagues.
The device is used 60-90 minutes a day and "works through directly stretching and/or angulating the penis and functions similar to other limb traction devices such as those used for scoliosis," he told MedPage Today.
The SMSNA study tracked patients for an additional 2 months in an open-label phase. Trost reported that "erectile function improvements in the treatment arm were sustained, even among men who stopped using traction at 6 months."
However, "those who continued to use the device beyond 6 months didn't show any greater benefits compared to what they had achieved up until 6 months post-op. This highlights that there is likely a key window where traction therapy should be used post-op," he noted.
A group of eight patients crossed over from the control group to the PTT group, and the results were "relatively similar to no treatment (except increase in length)," the authors wrote. Also, 10 patients who went from PTT to control retained improvements in penile length and erectile function.
"We didn't see a drop off," Trost noted. "This was a really important finding because with every other therapy ever tested, once the therapy is stopped, the improvements also stop."
The device appears to address perceptions of penile length loss after prostatectomy, if not necessarily the reality, Trost suggested. At 8 months, the mean increase in penile length was 1.8 cm in 12 men who continued PTT versus -0.01 in seven men who continued in the control group (P<0.01).
"Length loss after prostate surgery is actually debatable. Multiple studies have consistently shown that men post-prostatectomy perceive that their penile length is lost," he explained. "However, there are a few well-done studies, which sequentially measured penile length in men post-prostatectomy -- including our study -- which did not actually demonstrate length loss. It's not clear why there is this discrepancy between actual measured length and patient perception, although it likely is related to a reduction in erectile function, which then causes the penis to contract in more."
According to Trost, 40% of men treated on PTT who used it regularly reported their penises seemed slightly longer than prior to the operation. The other numbers were 30% (slightly shorter), 20% (no significant change), and 10% (much longer).
The device costs about $500 and is covered at least in part by most insurers, he said.
Alexander Pastuszak, MD, PhD, of the University of Utah Health in South Jordan, told MedPage Today that urologists have been using traction therapy for some time, "both for preservation of penile length after prostatectomy as well as for penile stretching in the treatment of Peyronie's disease. I routinely recommend it for men with Peyronie's disease who don't want surgical correction or injection therapies."
"What's most interesting about [the findings] are the claims about improvement in erectile function as a result of penile stretching," said Pastuszak, who was not involved in the study. "Given that, the likely hypothesis here is that stretching results in a physiologic change that increases nitric oxide and therefore blood flow into the penis; it would be really interesting to follow this up with further study to prove this."
He added that "with regards to patient satisfaction, there is likely some bias here on the part of the patients who were still in the study at the time of assessment, and these are patient-reported outcomes. But it's likely that satisfaction is relatively high."
While Pastuszak agreed that the may alarm some potential users, patients are more willing "once you talk to them about what [the device] does, and tell them how often and for how long they should use it, as well as the potential benefits."
He also noted that "there are a number of penile stretching devices on the market. At least one, the , is concealable so you can have it on as you're out and about."
Disclosures
The study was funded by the Mayo Clinic. PathRight Medical provided the device for the study at no cost.
Pastuszak disclosed relationships with Endo Pharmaceuticals, Contraline, Vault Health, and Inherent Biosciences.
Primary Source
Sexual Medicine Society of North America
Zganjar A, et al "Efficacy of RestoreX Penile Traction Therapy in Improving Penile Length and Erectile Function Post Prostatectomy" SMSNA 2021; Abstract 097.