MIAMI — Men receiving collagenase clostridium histolyticum (CCH; Xiaflex) injections for Peyronie’s disease had similar levels of overall satisfaction to surgery, and with fewer adverse effects, but they also experienced less curvature correction, a small randomized trial found.

All 40 patients in the randomized study received traction and sildenafil (Viagra), but no significant differences at 3 months were observed for the primary outcome of overall satisfaction between those who also received the CCH injections and those who underwent surgery (P=0.16):

• Very satisfied: 50% vs 21.1%, respectively
• Somewhat satisfied: 43.8% vs 63%

Meanwhile, the median percentage of curvature improvement at 3 months was 53.9% with CCH compared with 83.7% with surgery, while median length change was an increase of 6.3% versus a decrease of 4.1%, respectively (P<0.01 for both), reported Jacob Warner, a recent pre-medical graduate at Brigham Young University in Utah.

Adverse events, as well as patients’ subjective reports of treatment success favored CCH, according to his presentation at the Sexual Medicine Society of North America (SMSNA) annual meeting.

After the injection, “most people reported that they didn’t really need surgery,” Warner told MedPage Today, a finding he called surprising. “They were satisfied enough with the curvature improvement that they were happy with the results, though it was shown that surgery was much more effective” at correcting curvature.

Peyronie’s disease is a condition where fibrous tissue develops in the penis, leading to curved and painful erections. CCH is meant to break down collagen in the areas affected by Peyronie’s to reduce curvature, and is a longer treatment process than surgery. With double-incision surgery, the side opposite the scar tissue is stitched to correct the curvature.

Warner noted that non-surgical treatments appeal to some patients. “Many men, just when they hear the word surgery, they run the other way,” said Warner. “And so it’s a really great alternative for those individuals who will try anything but surgery.”

One treatment cycle of CCH consists of two injections administered by a physician or advanced practice provider 1 to 3 days apart, followed by a “penile modeling procedure” 1 to 3 days after the second shot. The cycle can be repeated every 6 weeks, up to four times.

Depending on insurance, however, surgery is typically the cheaper option for patients.

“That’s normally going to be the most economic of options, because it’s a one-time procedure,” said Warner, but he added that most health insurers will cover some of the costs for the CCH injections.

Adverse events were significantly more frequent with surgery (P<0.01), including pain (63.2% vs 6.3% with CCH), length loss (68.8% vs 20%), lumps (42.1% vs 18.8%), swelling (10.5% vs 6.3%), loss of sensation (57.9% vs 18.8%), and abnormal sensation (10.5% vs none). Discoloration was the only adverse event more frequent with CCH (6.3% vs none).

Subjective scores for erectile function, penile sensation, and penile length all favored the CCH group at 3 months. For example, better erectile function after treatment was reported in 62.5% of the CCH group versus 52.6% of surgery patients (P=0.03).

For penile sensation, a slightly higher proportion reported having more sensitivity following surgery (15.8% vs 6.3% with CCH), but far more surgery patients reported having less sensitivity (57.9% vs 12.5%; P<0.001). In terms of penile length, surgery patients were more likely to report shorter length following the procedure (50% vs 10.5%), while less likely to report longer length (5.3% vs 37.5%; P<0.0001).

Men enrolled in the study were an average age of 55, and eligible for either surgery or CCH treatment. Sildenafil and RestoreX, a penile traction therapy device that stretches the penis, were used for up to 3 months. Curvature was measured in two planes and summed, while length was measured from patients’ pubic symphysis to corona.

Men completed standardized, objective assessments, including the International Index of Erectile Function and Peyronie’s Disease Questionnaire at baseline, along with non-standardized assessments. Further follow-up is planned at various time points up to 5 years.

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