Is the RestoreX device safe and effective in the treatment of Peyronie’s disease?

This study examined if the RestoreX device is safe and effective in the treatment of Peyronie's disease (PD). This study concluded the RestoreX device improves curvature and increases the length of the penis in men with PD receiving intralesional therapy.

Peyronie’s disease (PD) involves an abnormal curvature of the penis when it is erect. The curvature is caused by scar tissue, called a plaque or lesion, forming in the penis. Surgery to remove the scar tissue is an option to treat PD, though it can be linked to complications. Other therapies include medication and mechanical devices. 

Intralesional therapy (ILT) injects proteins, or enzymes, which break down the plaques. Collagenase Clostridium histolyticum (CCH) is one type of ILT. Penile traction therapy (PTT) devices try to gently extend the penis and allow enzymes, to break down the plaque. There are many different types of device available. RestoreX is a PTT device worn for only 60-90 mins per day, a much shorter duration than many other PTT devices.

It is not known if the RestoreX device is safe and effective in the treatment of PD when compared to and used with other treatments. 

113 patients with Peyronie's disease were included in this study. Each of these patients had completed a course of CCH treatment. There were three treatment groups in this study. Group one received CCH alone. Group 2 received CCH and PTT, using a device other than RestoreX. Group 3 received CCH and used the RestoreX. 

After treatment, those in group 3 had a greater improvement in curvature and length of the penis. This was based on both accurate measurements and in the patients’ own opinion. Curvature improved by 49% in group 3, compared to 31% in group 1 and 30% in group 2. Length of the penis increased by 1.9cm in group 3 and decreased by 0.7cm in group 1 and by 0.4cm in group 2. When asked for their opinion, patients believed the curvature improved by 63% in group 3, compared with 44% in group 1 and 32% in group 2. 

Group 3 were 6.9 times more likely to achieve at least a 20° improvement in curvature. They were 3.5 times more likely to achieve at least 50% curvature improvement. They were 10.7 times more likely to experience at least a 20% improvement in length. The RestoreX was used for an average of 0.9 hours per day, with the other devices used for 1.9 hours per day.

Side effects were similar in all three groups. 100% of men had discoloration of the penis due to bleeding underneath the skin at some point during CCH therapy. There was one penile fracture suspected in group 1, 2 fractures in group 2, and none in group 3. 

This study concluded the RestoreX device improves curvature and increases the length of the penis in men with PD receiving intralesional therapy.

This was a small study, larger studies are needed.