Rigi10™ Malleable Penile Prosthesis
Also Known As
Clostridiopeptidase A, Clostridium histolyticum collagenase, Collagenase, Santyl, Xiaflex, Qwo, Collagenase clostridium histolyticum-aaes, CCH, AUX-I and AUX-II.²
Definition
Collagenase Clostridium Histolyticum (CCH) is an enzyme preparation derived from the bacterium Clostridium histolyticum. It is composed of a mixture of two purified collagenases, AUX-I and AUX-II, which are proteinases that selectively hydrolyze collagen. ¹˒² These enzymes work synergistically to break down the triple-helical structure of collagen, leading to the lysis of collagen deposits. ³ The primary purpose of CCH in urology is as a non-surgical treatment option for Peyronie’s disease (PD), where it targets and degrades the collagenous plaques within the tunica albuginea of the penis that cause penile curvature and deformity. ¹˒⁴ It is also used in the treatment of Dupuytren’s contracture, a similar fibroproliferative disorder affecting the hand. ² Additionally, a topical formulation of collagenase is used for the enzymatic debridement of chronic dermal ulcers and severely burned tissues by removing necrotic tissue and promoting healing. ⁵ More recently, an injectable form has been approved for the treatment of moderate to severe cellulite in adult women, where it targets the fibrotic septae responsible for the dimpled appearance of the skin. ⁶
Clinical Context
Collagenase Clostridium Histolyticum (CCH) is utilized clinically for conditions characterized by excessive or pathological collagen deposition. Its primary application in urology is the treatment of Peyronie’s disease (PD) in adult men who present with a palpable plaque and penile curvature deformity, typically of at least 30 degrees at the start of therapy.1˒3 Patient selection for CCH treatment in PD involves a thorough evaluation, including medical history, physical examination to characterize the plaque (size, location, consistency), and assessment of penile curvature, often with a pharmacologically induced erection and duplex Doppler ultrasound.1˒7 Ideal candidates are those with stable disease (typically for at least 6-12 months, with no worsening of curvature or pain for at least 3-6 months) and a clearly palpable plaque amenable to injection. It is generally not recommended for patients with ventral plaques, hourglass deformities without a discrete plaque, or calcified plaques that are unlikely to respond to enzymatic digestion.1
The procedure involves intralesional injections of CCH directly into the Peyronie’s plaque. A treatment course typically consists of up to four treatment cycles. Each cycle involves two injection procedures administered 1 to 3 days apart, and the cycles are repeated approximately every 6 weeks.3˒4 Between 24 and 72 hours after the second injection of each cycle, a penile modeling procedure (gentle stretching and straightening of the penis) is performed by the healthcare provider, and patients are also instructed on how to perform home penile modeling exercises daily for the duration of treatment.3 This combination of enzymatic plaque disruption and mechanical modeling aims to reduce the penile curvature and improve deformity.
Expected outcomes include a statistically significant reduction in penile curvature deformity and a decrease in the bother reported by patients due to their PD symptoms.1˒3 Clinical trials (e.g., IMPRESS I and II) have demonstrated mean improvements in penile curvature of approximately 34% (around 17 degrees) compared to about 18% (around 9 degrees) in placebo groups.3 Patients may also experience improvements in plaque consistency. The onset of improvement can be observed as early as week 6 of treatment and can continue through the treatment course and follow-up period.3˒9 Recovery from each injection procedure typically involves localized reactions such as penile bruising, swelling, pain, and hematoma, which are usually transient and resolve within days to weeks.1˒3 Serious adverse events, though rare, can include corporal rupture (penile fracture) or other severe penile injuries, necessitating careful patient selection, injection technique, and post-procedure instructions, including avoidance of sexual activity for a period after treatment.1
Beyond Peyronie’s disease, CCH (Xiaflex) is also FDA-approved for Dupuytren’s contracture in adults with a palpable cord, where it is injected into the collagen cord to facilitate its disruption and improve finger extension.2 A topical formulation (e.g., Santyl) is used for the debridement of chronic dermal ulcers (like pressure ulcers, diabetic ulcers, venous stasis ulcers) and severely burned areas, by enzymatically removing necrotic tissue to promote wound healing.5 More recently, an injectable formulation (Qwo) has been approved for the treatment of moderate to severe cellulite in the buttocks of adult women, targeting the fibrous septae that cause skin dimpling.6