For the last few years, intralesional injections of collagenase clostridium histolyticum (CCH) have been a nonsurgical option for treating Peyronie’s disease. However, the therapy can have some serious side effects, including corporal rupture (penis fracture) and hematoma formation (blood accumulation under the skin).
A recent survey of 100 members of the Sexual Medicine Society of North America (SMSNA) provided some insight on the prevalence of these adverse events and how CCH prescribers manage them.
Peyronie’s disease is believed to be a connective tissue disorder that causes areas of hardened scar tissue called plaques to form on the penis. Because of these plaques, the penis loses some of its flexibility and begins to curve, making intercourse difficult. Many men experience pain.
First approved by the U.S. Food and Drug Administration (FDA) in December 2013, CCH injections are marketed under the brand name Xiaflex. Injections are given in a series of two-dose cycles, with instructions for patients to gently straighten the penis for 6 weeks after each cycle.
All of the survey respondents were CCH prescribers. They answered 33 questions on their experiences with CCH, with special focus on the development of hematomas and corporal rupture.
Corporal rupture occurs when one of the corpora cavernosa breaks during erection. Hematomas can form when blood vessels break and blood collects or clots. Both have been linked to CCH treatment of Peyronie’s disease.
The survey revealed the following:
• For 94% of the clinicians, hematomas formed in less than 25% of their patients.
• To prevent hematomas from forming, 54% of the respondents asked patients to stop taking antiplatelets and anticoagulants before injections. Thirty-seven percent of the clinicians used no dressing; half instructed patients to remove the dressing the day after the injection.
• If hematomas did form, about two-thirds of the respondents used an observation approach alone. Twenty percent said they used a compressive dressing alone. Most reported delaying an injection if a severe hematoma occurred.
• Thirty-four percent had had a patient with a corporal rupture. Of these, most of the clinicians – 79% – had just seen one incident. Two-thirds of them treated the rupture surgically.
Vigorous intercourse was a common cause of corporal rupture. CCH prescriber information recommends that patients abstain from sexual activity for two weeks after the second injection of their treatment cycle. In this study, however, 44% of the corporal ruptures occurred after this two-week point.
“These results suggest that, perhaps, patient counseling following CCH should be amended to recommend ‘patients exert caution and refrain from vigorous intercourse within the first 30 days after the second injection of a treatment cycle,’” the study authors wrote.
They added that both surgical and conservative approaches to treating ruptures had similar outcomes in terms of curvature, erectile function, and satisfaction among patients and doctors. They noted that it is “undetermined if there is a benefit of surgery over conservative management.”
The study was published last month in the Journal of Sexual Medicine.
“Xiaflex Medication Guide”
The Journal of Sexual Medicine
Yafi, Faysal A. MD, et al.
“Results of SMSNA Survey Regarding Complications Following Intralesional Injection Therapy With Collagenase Clostridium Histolyticum for Peyronie’s Disease”
(Full-text. April 2016)