AB041. Experience in the use of collagenase clostridium histolyticum in the management of Peyronie’s disease
Prospective Study with a reported sample of 6 on Scar, published in Transl Androl Urol (2016) — summary generated from the PubMed abstract.
Early human evidence such as case series or small samples is exploring possible benefits.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
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- Study type
- Prospective Study
- Journal
- Transl Androl Urol (2016)
- Reported sample size
- 6
- Source database
- Europe PMC
- PMCID
- PMC4842706
Abstract (original English)
Background Peyronie’s disease (PD) is a chronic disorder characterized by formation of fibrous inelastic scarring of tunica albuginea of the penis resulting in variety of penile deformities. In most cases, PD is accompanied by physical and psychological impact. Xiaflex® is an injectable collagenase clostridium Histolyticum (CCh) preparation consisting of mixture of two distinct collagenases class I (AUX-I) and class II (AUX-II) clostridial collagenases. Recently the US Food and Drug Administration (FDA) approved Xiaflex® for the non-surgical treatment of men with PD with curvature of 30° or more and tangible scar tissue plaque in their penis. Methods We enrolled a total of 6 patients with diagnosis of PD in the trial to study the efficacy and safety of CCh. All patients have stable dorsal plaque with penile curvature of more than 30° at time of enrollment (degree of curvature was measured and documented by pictures were taken to the patients). Informed consent was taken from each patient explaining the potential risk of developing ecchymosis, penile hematoma at site of injection, minor risk of penile fracture was explained as well. Results Three patients have more than 30% improvement in curvature, 2 patients have less than 30% improvement and one patient show no improvement. All patients had minor bruises at the base of the penis and site of injection after each injection Conc
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Early human evidence such as case series or small samples is exploring possible benefits.
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