Preliminary Clinical Results
A randomized, controlled clinical trial using the RestoreX device in men with Peyronie’s disease is taking place at Mayo Clinic. Results were presented at the American Urological Association meeting in May, 2018. The results were encouraging and are summarized below.
The study is designed to randomly assign up to 120 men to one of four treatment categories: 1 – no treatment (control), 2 – RestoreX 30 min daily, 3 – RestoreX 60 min daily, and 4 – RestoreX 90 min daily. The study was designed with a “control” group that did not use any therapy allowing for a direct comparison between RestoreX and the “no treatment” group. The study is the only randomized, controlled study performed to date on the effect of traction therapy in men with Peyronie’s disease.
Preliminary Study Results
After 12 weeks of treatment, men receiving two, 30-minute RestoreX treatments achieved an average 15-degree reduction (improvement) in curvature, a 34% reduction from baseline. In contrast, the control group exhibited a 3-degree reduction or 7% improvement from their starting point. These results were statistically significant, meaning the results were likely due to RestoreX rather than chance alone.
Note: nearly 50% of men in this study had a prior treatment for PD and an average time of PD of 4.5 years (difficult to treat group)
Curvature after 12 weeks
|RestoreX||Control (no treatment)|
|Change in curvature (degrees)||-15°||-3°|
|Percent change in curvature compared to baseline||-34%||-7%|
Increases in penile length were also recorded. The results included a 2.0 cm gain or 12% in the RestoreX group versus a 0.3 cm gain or 2.5% in the control group. All results were statistically significant.
Length after 12 weeks
|RestoreX||Control (no treatment)|
|Change in length (cm)||+2.0 cm||+0.3 cm|
|Percent change in length compared to baseline||+12%||+2.5%|
The study also tracked complications (adverse events). These were determined at baseline and after 12 weeks of treatment with RestoreX. All symptoms related to the use of RestoreX resolved within a few minutes of stopping a treatment. No men experienced any permanent new complications from the treatment.
*All symptoms resolved within a few minutes of stopping a treatment.
|Discoloration (blue color)||3 Men (11% of total)||11 Men (42% of total), resolved in < 5 min|
|Decreased penile sensation||8 Men (30%)||8 Men (30%) (no change from baseline)|
|Cold glans (head of penis)||0 Men||1 Man (4%), resolved in < 5 min|
|Minor penile discomfort||4 Men (15%)||16 Men (67%), resolved in < 5 min|
|Penile discomfort lasting > 5 min||0 Men||1 Man (4%) resolved after 30 min|
RestoreX is the only penile traction device, in a randomized controlled clinical trial, to show:
- Improvement in length
- Improvement in penile curvature
- Safety of use
- Statistically significant improvements in penile curvature in the chronic phase of disease
- Improvements with 60 minutes daily use
- Improvements after 3 months after use
Results of the study revealed other interesting findings.
- Note: nearly 50% of men in this study had a prior treatment for PD and an average time of PD of 4.5 years (difficult to treat group)
- 70% of men were very or somewhat satisfied with the RestoreX device, while 27% were neutral and 4% somewhat dissatisfied (0% very dissatisfied)
- Men treated with traction reported higher rates of improvements regarding penile pain, bother with PD, and psychological impact of PD compared to the no treatment group (control group).
- Men treated with traction reported improved erectile function and satisfaction with intercourse compared to controls
- 70% of men who used traction indicated that traction with RestoreX would be their preferred therapy to treat PD if they were starting treatment for the first time.
- All men who had used another traction device before RestoreX stated that RestoreX was either much better (83%) or somewhat better (17%) than other devices