Preliminary Clinical Results
A randomized, controlled clinical trial using the RestoreX device in men with Peyronie’s disease is taking place at Mayo Clinic. Updated preliminary results were presented at the 19th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) in November 2018.
The results are summarized below.
The study randomly assigned 110 men to one of four treatment categories:
- No treatment (control)
- RestoreX 1, 30-minute treatment/day
- RestoreX 2, 30-minute treatments daily (total of 60 minutes)
- RestoreX 3, 30-minute treatments/day (90 minutes total).
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 one of only two randomized, controlled studies evaluating traction therapy in men with Peyronie’s disease. It will be the largest study ever conducted using traction therapy in men with PD and is the only randomized, controlled trial evaluating the use of traction for 2, 30-minute treatment sessions per day. It is also the only study to incorporate an “intent to treat” analysis meaning results were presented for all men who entered the study, not just those doing the treatment perfectly.
Preliminary Study Results – improvement in length, curve and erectile function
The presentation at the SMSNA meeting reported on 58 men using RestoreX for 12 weeks of treatment. For the men in the study, the average time since diagnosis was just under 4 years, meaning most men were in the chronic phase of the condition. On average, 78% of men experienced improvements in curvature. Of those, the average improvement was 18-degrees, a 30% reduction from baseline. In contrast, the control group exhibited a 1-degree reduction or 2.4% improvement from their starting point. These results were statistically significant, meaning the results were likely due to RestoreX rather than chance alone.
Curvature after 12 weeks
|RestoreX||Control (no treatment)|
|Change in curvature (degrees)||-18°||-1°|
|Percent change in curvature compared to baseline||-30%||-2.4%|
Of the nearly 80% or 4 in 5 men experiencing reduction in curvature, 50% achieved greater than a 20% reduction in curve
Increases in penile length were also recorded. The results included a 1.6 cm gain or 11% in the 94% of men in the RestoreX group that showed improvement in length versus a 0.3 cm gain or 2.1% in the control group. All results were statistically significant.
Length after 12 weeks
|RestoreX||Control (no treatment)|
|Change in length (cm)||+1.6 cm||+0.3 cm|
|Percent change in length compared to baseline||+11%||+2.1%|
Approximately 19 in 20 study participants experienced an improvement in length after just 12 weeks of treatment. Approximately 30% of men in the trial experienced greater than a 2.0cm increase in length.
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 and no men stopped using RestoreX as a result of the events listed below.
*All symptoms resolved within a few minutes of stopping a treatment.
|Discoloration (blue color)||21 Men (39% of total), all resolved in < 5 min|
|Decreased penile sensation||8 Men (15%) (6 resolved < 5 min, 2 > 24 hours but resolved by next visit)|
|Cold glans (head of penis)||2 Men (4%), all resolved in < 5 min|
|Minor penile discomfort||23 Men (44%), all resolved in < 5 min|
|De-Novo curvature||0 Men (0%)|
Preliminary Study Results – improvements in ability to penetrate and overall satisfaction and recommendations
RestoreX treatment for 12 weeks also improved men’s sexual function. Average Erectile Function scores for men in the trial increased by 2.7 points compared to men in the control group that saw a decline of 0.3. Additionally, men in the trial noted a 0.9-point improvement in intercourse satisfaction compared to a 0.3-point decline in the control group.
At the beginning of the trial 47% of men reported they were unable to have penetrative sex. After twelve weeks of treatment using the RestoreX device, 80% of these men, a total of 38% reported an improved ability to penetrate.
Results of the study revealed other interesting findings.
As shown below, 66% of men were very or somewhat satisfied with the RestoreX device, while 31% were neutral and just 3% somewhat dissatisfied (0% very dissatisfied)
73% 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.
Notably, all men who had used another traction device prior to starting the clinical trial stated that RestoreX was either much better (87%) or somewhat better (13%) than the other traction device(s) they had previously used.
In summary, RestoreX is the only penile traction therapy device shown in a randomized controlled clinical trial to improve penile length and curvature in either 1, 2 or 3 30-minute treatment sessions per day for 12 weeks. Other traction products required up to 8 hours of daily use. In addition, men who used RestoreX experience improvements in erectile function, overall, compared to those in the control group. Finally, the results of the clinical trial demonstrated safety with only mild, temporary side effects with use.
The clinical trial completed enrolling patients in August 2018. Updated results should be available again in the Spring of 2019.