Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Patients and Their Female Partners
Irwin Goldstein, MD; L. Dean Knoll, MD; Larry I. Lipshultz, MD; Ted Smith, PhD; Gregory J. Kaufman, MD; Chris G. McMahon, MBBS
ONLINE: April 5, 2017 – Sexual Medicine
Peyronie’s disease (PD) is a wound-healing disorder that results in the formation of plaques on the tunica albunginea, which can lead to curvature or indentation of the penis, length loss, and erectile dysfunction (ED). The condition can be quite distressing and lead to relationship and emotional problems for patients. Little is known about the effects of PD on sexual partners.
Intralesional injection therapy with collagenase Clostridium histolyticum (CCH) has been approved by the U.S. Food and Drug Administration (FDA) for men with PD who have palpable plaques and a curvature of at least 30 degrees. Efficacy of CCH was shown in two double-blind, randomized, placebo-controlled, phase 3 studies: Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies I and II (IMPRESS I and II).
The current study aimed to assess the safety and efficacy of CCH in men who received placebo treatments in the IMPRESS I and II studies. It also analyzed the perspectives of female partners.
The study, which was conducted between September 2012 and December 2013, involved 189 men with PD (mean age 60 years) who had curvature between 30 degrees and 90 degrees with no previous PD surgery.
Each man underwent up to four treatment cycles. Each cycle included the following steps:
• Two injections of CCH spaced 24 to 72 hours apart.
• After another 24 to 72 hours, investigator modeling of the penile plaque.
• Six weeks of daily modeling performed by the patient at home.
• Cycle repeated after 6 more weeks.
Men received up to 8 injections of CCH in total.
Thirty female partners also participated in the study. Ninety percent of the women were postmenopausal.
Main Outcome Measures
Researchers determined the change or percentage of change in penile curvature and the change in the PD symptom bother domain score of the Peyronie’s Disease Questionnaire (PDQ) occurring between baseline and week 36. The PDQ was completed only by men who had had vaginal intercourse with a female partner during the previous 3 months. Safety assessments included adverse events, vital signs, and clinical laboratory evaluations.
Women completed a version of the PDQ designed for female partners (PDQ-FSP) and the Female Sexual Function Index (FSFI). These assessments were taken at baseline and at the 36-week point.
Results and Discussion
Mean penile curvature deformity decreased from 46.9 degrees to 29.9 degrees. The mean percentage of improvement was 36.3%. Mean PDQ bother scores decreased from 6.3 at baseline to 3.9 at 36 weeks, with a mean decrease of 2.4 points.
Results were similar when the researchers adjusted for baseline scores on the International Index of Erectile Function (IIEF).
Approximately 96% of patients experienced at least one adverse event; about 93% had treatment-related adverse events, most of which were mild to moderate. The most common adverse events were penile hematoma (60.3%), penile pain (34%), and penile swelling (30%). About 73% of treatment-related adverse events resolved within 14 days.
Female partners had statistically significant improvements in their PDQ-FSP scores, noting improvement in their partner’s PD symptoms and improvements in their own distress levels. About 70% of the women said their sex lives had gotten better with their partner’s treatment. About 57% said their relationship with their partner had improved.
Women’s sexual function also improved. At baseline, 75% of the women scored in the dysfunctional range of the FSFI. At week 36, this rate fell to 33.3%.
The authors acknowledged several limitations, including the open-label study populations, the inclusion of only heterosexual couples, and the small number of female participants. However, “the findings are consistent with previous studies and add to our knowledge of the efficacy and safety of CCH,” they wrote. They added that this study was the first, to their knowledge, to investigate the effects of PD and PD treatment on sexual partners.
“This represents an important step in evaluating the effects of PD beyond the patient with PD and the patient’s own views of his health and the health of his relationships,” they wrote.