Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Manaf Alom MBBS; Kiran L. Sharma PhD; Amir Toussi MD; Tobias Kohler MD; Landon Trost MD

FIRST PUBLISHED: April 4, 2019 – The Journal of Sexual Medicine

DOI:https://doi.org/10.1016/j.jsxm.2019.03.007

Introduction

Penile traction therapy (PTT) devices are used to lengthen the penis. Past studies of their effectiveness in men with Peyronie’s disease have had mixed results.

Developed with the cooperation of the Mayo Clinic, the RestoreX penile traction device addresses some of the limitations of previous devices by incorporating “a new clamping mechanism, greater traction force, the ability to dynamically lengthen traction without removing the device, visible indicators of adequate traction, and counterbending in 4 primary directions.”

Clinical trials in men with Peyronie’s disease who used the RestoreX device for 3 months found improvements in length, curvature, and erectile function compared with controls. Men wore the device for 30 to 90 minutes each day – less time than the 3 to 5 hours a day needed with other devices.

This study investigated the use of RestoreX as an adjunctive therapy along with intralesional injections of Clostridium histolyticum (CCH).

The primary outcomes of this study were changes in penile curvature (absolute and percent). Secondary outcomes were adverse events, subjective measures of success, restored ability to penetrate, and/or improved curvature.

Materials and Methods

The participants were 113 men with Peyronie’s disease who underwent CCH injections at one institution between March 2014 and January 2019.

For comparison, the men were divided into 3 groups:

• Group 1 (52 men, median age 56) was treated with CCH alone.
• Group 2 (45 men, median age 59) was treated with CCH and any traction device that was not the RestoreX device, such as the AndroPenis, X4Labs, and PeniMaster.
• Group 3 (16 men, median age 57) was treated with CCH and the RestoreX device.

Curvature assessments were made at baseline and again before the third series of injections and 6 weeks after the fourth series of injections.

The men were told to avoid penetrative intercourse for 4 weeks and to perform hand modeling (30 seconds straight, 30 seconds counterbending) every time they urinated.

Results

On average, the men in Group 2 used their traction devices for 1.9 hours a day, while the men in Group 3 used the RestoreX devices for an average of 0.9 hours a day.

Group 3 had significantly greater improvements in curvature and length compared to Group 1 and Group 2. They also had greater subjective improvements in curvature and restored/improved penetration.

Compared to the men in Group 1 and Group 2, the men in Group 3:

• Were 6.9 times more likely to see a curvature improvement ≥20 degrees.
• Were 3.5 times more likely to achieve curvature improvement ≥50%.
• Were 16.9 times more likely to achieve a length gain of at least 1 centimeter.
• Were 10.7 times more likely to have a length increase of at least 20%.

Results were also analyzed for a subset of men who used their non-RestoreX PTT devices for 3 or more hours a day while receiving CCH injections. Sixteen percent of the men for whom this time period was recommended were able to meet that goal. When compared to men who underwent CCH alone, there were no significant differences in absolute curvature, percent curvature, absolute length, and percent length.

Adverse events were similar across the 3 groups. All of the men experienced ecchymoses at some point. Hematomas were found in 31% of Group 1, 50% of Group 2, and 19% of Group 3. Other adverse events were fractures, diffuse joint pain, difficulty sleeping, and the sensation of blood rushing to the head during orgasm.

Discussion

Compliance

The findings “highlight the challenge and importance of compliance with prescribed therapies.” Among the men who used a device other than the RestoreX, 16% used the device for the recommended minimum of 3 hours each day, and 9% used it for the recommended ≥5 hours each day.

However, most of the men who used a device were able to do so for 30 minutes a day (92% of the men in Group 3 and 87% of the men in Group 2).

“Thus, the ability to achieve significant improvements with a shorter duration of PTT use is critical to the clinical utility of the therapy,” the authors wrote.

Mechanism for Improved Outcomes

Compared to other PTT devices, RestoreX uses greater force, dynamic advancement, and counterbending.

“It is possible that the RestoreX device generates additional or greater duration of directed forces to effect curvature correction compared with manual modeling alone, accounting for our present findings.”

Limitations

The study had several limitations, including the following:

• It was not a randomized controlled trial.
• Validated PDQ assessments were not administered routinely.
• The study took place at one site only.
• The sample size was small.

Conclusions

For men with Peyronie’s disease, CCH therapy accompanied by penile traction therapy with the RestoreX device is associated with greater improvements in penile length and curvature (including subjective perception) than CCH alone or CCH combined with other PTT devices.