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Researchers at the Mayo Clinic report that they have developed a legitimate penile traction therapy device for men with Peyronie’s disease that may work when used for just 30 to 90 minutes daily.
Researchers at the Mayo Clinic report that they have developed a legitimate penile traction therapy (PTT) device for men with Peyronie’s disease (PD) that may work when used for just 30 to 90 minutes daily.
Investigators looked at the device (RestoreX) in a recent study, and preliminary findings suggest using it for 30 to 90 minutes daily may result in statistically significant improvements in penile length and curvature after 3 months with no significant adverse events.
“We were a bit surprised by the findings. Up until this study and the creation of this device, no traction device had shown efficacy when used for less than 3 hours a day, with many studies requiring 6 to 8 hours daily. Even then, the studies often showed very minimal or mixed results,” said study investigator Landon Trost, MD, a urologist at Mayo Clinic, Rochester, MN.
Dr. Trost and his colleagues assessed the safety and efficacy of the RestoreX PTT device in 120 men with PD, who were randomized to one of four groupings (RestoreX for 30 minutes once per day, RestoreX for 30 minutes twice per day, RestoreX for 30 minutes three times per day, or a control group). All the men were treated for 3 months and then entered an open-label phase for an additional 3 months.
The authors found that PTT significantly improved penile length (+1.4 cm [+9.9%] vs. +0.3 cm [2.1%], p<.01) and helped with primary penile curvature (–9 degrees [–18.9%] vs. –1.0 degrees [–2.4%], p<.01) versus controls after 3 months of treatment. There were also significant improvements in the psychological/physical domain of the questionnaires for the treatment arms (PTT –2.6 vs. –0.5, p=.01). Significant improvements were seen in the ability to penetrate compared to baseline, with 38% reporting restored ability to penetrate versus 0% in the controls (p<.01). The authors also found that 19% of the PTT-treated men were able to eliminate their need for surgery.
Dr. Trost said in his practice he had not seen clinical improvements using previously existing devices, and it was nearly impossible to get men to use the older devices for 3 hours or more daily.
“Although we had expected to see modest improvements in length and curve, we were surprised by the percentage of men achieving a successful result; 94% and 77% experienced length and curvature improvements, respectively. The most surprising finding of the study, though, was that it appeared to improve erectile function by a clinically meaningful amount,” Dr. Trost told Urology Times.
The study, which was presented at the AUA annual meeting in Chicago, included 117 men. The authors had 3-month data available on 85 patients (66 patients in PTT arms and 19 controls). The mean age of the men was 58.4 years, and the mean duration of PD was 45 months. The mean primary curvature was 45.7 degrees and mean stretched penile to coronal length was 11.5 (1.4) cm, which was non-significant between PTT patients and controls.
Safety was the primary outcome for the study, and secondary outcomes included penile length, curvature, and subjective responses to standardized (IIEF, PDQ) and non-standardized questionnaires. The authors conducted assessments at baseline and 3 and 6 months after starting therapy, and they found that adverse events with PTT were all mild and resolved quickly after completing therapy. They included mild discomfort (44%), erythema (39%), and sensory changes (15%).
“For this study, we picked a very difficult to treat group, all-comers, including those with prior surgery, hourglass, injections, chronic phase, calcification, etc., and used an intent-to-treat analysis. We also blinded our team performing measurements so that the impact of our biases couldn’t influence the outcomes,” Dr. Trost said.
Curvatures were assessed from before/after photographs that were reviewed without knowledge as to the patient’s assignment (control vs. device).
“We really wanted to know if this therapy truly worked or not. We have no tolerance for introducing another ‘snake oil’ into the men’s health arena,” said Dr. Trost.
Next: Several roles for deviceSeveral roles for device
He said there are a few roles for the device. It could be used as a stand-alone therapy for PD to improve length and curvature, as an additive therapy with collagenase clostridium histolyticum (XIAFLEX) to significantly enhance curvature outcomes and increase length, or to restore length in men who have lost length due to medical conditions such as diabetes or have undergone a prostatectomy.
“Given its cost-effectiveness compared to other treatments and minimal side-effect profile, it would make sense as a first-line therapy. I think it’s too early to know if it has a role in improving erectile function or if it makes sense to use in other scenarios, such as pre-penile prosthesis for example,” Dr. Trost said.
He said the benefit of penile traction therapy in general is that it is very safe, with only minor/transient side effects. The downside is that it takes time to see improvements, particularly with curvature.
Edward Cherullo, MD, a urologist at Rush University Medical Center, Chicago, said with many of these patients, the management of scar tissue is the major issue.
“I think it has some utility in the properly selected patients,” Dr. Cherullo told Urology Times.
“I think it is promising. It is not surgical or a pharmacological approach. The surgery and injections are not without risks,” said Dr. Cherullo, who was not involved with the study.
The technology behind the aforementioned device was developed by Dr. Trost in cooperation with Mayo Clinic Ventures. To mitigate potential conflicts, Dr. Trost elected to not invest in the licensing company in order to be able to perform research studies evaluating its efficacy