Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study
David J. Ralph, FRCS; Amr Abdel Raheem, PhD; and Genzhou Liu, PhD
ONLINE: September 30, 2017 – The Journal of Sexual Medicine
Peyronie’s disease is believed to be a wound-healing disorder of the penis that results the formation of plaques and penile deformity. Some men also experience pain and emotional distress.
Injections of Collagenase Clostridium histolyticum (CCH) have been approved by the U.S. Food and Drug Administration for the treatment of Peyronie’s disease in men with palpable plaques and curvature of at least 30 degrees.
The American Urological Association includes CCH, in conjunction with penile plaque remodeling, in its guidelines for Peyronie’s treatment in men with stable disease, curvature ranging from 30 degrees to 90 degrees, and intact erectile function.
This prospective, randomized, open-label pilot study explored the effects of vacuum-pump therapy, with and without penile modeling, in men receiving CCH. The authors noted that penile modeling and vacuum therapy “share underlying physiologic mechanisms.”
Thirty men participated in the study, which took place at one site in the United Kingdom between October 2014 and March 2016. Their mean age was 57.7 years and their mean curvature was 58.7 degrees. Both groups had similar baseline demographic and disease characteristics.
The patients were randomly assigned to one of two groups:
- CCH plus vacuum-pump therapy with investigator-administered plaque remodeling
- CCH plus vacuum-pump therapy alone
A CCH treatment cycle consisted of two intralesional injections of CCH (0.58 mg) spaced approximately 24 to 72 hours apart. If needed, men received up to four six-week treatment cycles for a total of eight injections.
Participants were taught to use the vacuum pump correctly. They used the pump twice daily starting 14 days after the second CCH injection in each cycle, continuing to the next treatment cycle.
Plaque remodeling occurred 24 to 72 hours after the second CCH injection in each cycle. During remodeling, the investigator “grasped the hardened portion of the plaque of the non-erect penis . . . and applied steady pressure to elongate and stretch the penis.” This was done twice at 30-second intervals. Patients did not do modeling at home.
The following tools were used to evaluate the patients’ progress:
- Measurement of penile curvature
- The Peyronie’s Disease Questionnaire (PDQ)
- International Index of Erectile Function (IIEF)
- Global Assessment of Peyronie’s Disease assessment tool
- Safety assessments
Results and Discussion
The following results were found at a 36-week assessment point.
At week 36, both groups saw similar improvements, with a curvature decrease of 23.7 degrees for the CCH + vacuum + modeling group and 23.3 degrees for the group without modeling.
General PDQ scores, along with scores for the symptom severity and bother domains, improved for both groups. These changes “reflected the relief of [Peyronie’s disease] symptoms and the potential enhancement of quality of life,” the authors wrote.
However, penile pain domain scores increased in the group with modeling and slightly decreased in the group without modeling (suggesting improvement).
Scores on the erectile function and intercourse satisfaction domains of the IIEF improved from baseline to week 36 in the CCH + vacuum group but were slightly worse or the CCH + vacuum + modeling group. The latter result “could be artifact of penile discomfort attributable to penile modeling,” the authors said.
Both groups had improvements in their overall satisfaction domain scores, but the CCH + vacuum group had greater improvements.
Composite responders met the following criteria:
• A decrease in curvature of at least 20 degrees from baseline to week 36, and
• A decrease in PDQ bother score of at least 1 point from baseline to week 36, or
• A change from reporting “no sexual activity” to “sexual activity” at week 36
In the CCH + vacuum + modeling group, 66.7% of the men met these criteria. For the CCH + vacuum group (with no modeling), the rate was 84.6%.
Safety and Tolerability
All of the patients reported at least one adverse event, but most events were mild to moderate. Penile contusion, swelling, and pain were the most commonly reported events.
Limitations of the study included the small sample size, lack of formal statistical analyses, and limited follow-up duration.
“Sample size was not formally calculated; however, the study sponsor stated that a sample of approximately 30 patients would be adequate for this pilot study,” the authors noted.
More research is needed to determine the optimal duration and frequency of vacuum-pump administration and to determine which patients are the best candidates for this approach.
“CCH and vacuum-pump therapy (alone or combined with modeling) could be an appropriate consideration for men with [Peyronie’s disease] and warrants further investigation,” the authors concluded.